VARIABLE ANGLE LOCKING HAND SYSTEM - …synthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes International... · Variable Angle Locking Hand System Surgical Technique DePuy Synthes

VARIABLE ANGLE LOCKINGHAND SYSTEMFor fragment-specific fracture fixation withvariable angle locking and locking technology

SURGICAL TECHNIQUE

Instruments and implants approved by the AO Foundation.This publication is not intended for distribution in the USA.

Image intensifier control

This description alone does not provide sufficient background for direct use of DePuy Synthes products. Instruction by a surgeon experienced in handling these products is highly recommended.

Processing, Reprocessing, Care and MaintenanceFor general guidelines, function control and dismantling of multi-part instruments, as well as processing guidelines for implants, please contact your local sales representative or refer to:http://emea.depuysynthes.com/hcp/reprocessing-care-maintenanceFor general information about reprocessing, care and maintenance of Synthes reusable devices, instrument trays and cases, as well as processing of Synthes non-sterile implants, please consult the Important Information leaflet (SE_023827) or refer to: http://emea.depuysynthes.com/hcp/reprocessing-care-maintenance

Variable Angle Locking Hand System Surgical Technique DePuy Synthes 1

INTRODUCTION

SURGICAL TECHNIQUE

PRODUCT INFORMATION

TABLE OF CONTENTS

Variable Angle Locking Hand System Overview 2

AO Principles 5

Intended Use and Indications 6

Featured Plates and Technique Highlights 7

Screws in the System 18

Featured Instruments 20

Preoperative Planning and Reduction 27

Lag Screw Insertion (Optional) 29

Prepare and Insert Plate 37

Trial Implants 37

Insert Screw 50

Implant Removal 51

Implants 54

Kirschner Wires 63

Instruments 64

Optional Instruments 68

Trial Implants 69

Case Components and Modules 73

Also Available 76

MRI Information 77

1 DePuy Synthes Variable Angle Locking Hand System Surgical Technique

The DePuy Synthes Variable Angle Locking Hand System consists of plates that are anatomic, procedure-specifi c, and available in both stainless steel and titanium.

The Variable Angle Locking Hand System offers instrumentation to aid in: fracture reduction provisional fi xation plate adaptation construct creation

Designed for the Surgeon and Patient

A dedicated, global surgeon team was integral to the design of this system through extensive consultation and participation in multiple design labs. Surgeon interviews, design and development meetings, and collaboration with key opinion leaders determined the clinical components necessary for the DePuy Synthes Variable Angle Locking Hand System. DePuySynthes Companies are dedicated to improving patient care.

System Snapshot

Extensive system of anatomically precontoured plates First to the market with 1.3 mm locking screws for

hand plating1

Forceps that aid in fracture reduction and lag screw application

Forceps that aid in plate fi xation Self-retaining screwdrivers Plates available in 316L stainless steel and titanium Color-coded instruments

VARIABLE ANGLE LOCKING HAND SYSTEM OVERVIEW

1 DePuySynthes Companies market analysis of leading orthopaedic companies, conducted May 2015.


SYSTEM TECHNOLOGYVariable Angle Locking Technology

Variable Angle Locking Plates 1.5 mm and 2.0 mm feature Variable Angle Locking coaxial holes. Four columns of threads in the Variable Angle Locking hole provide four points for threaded locking between the Plate and the Variable Angle Locking Screw to create a fixed-angle construct at the desired screw angle. Variable Angle Locking plate 1.5 holes accept:

Variable Angle Locking screwsB1.5 mm Cortex screwsB1.5 mm Locking screwsB1.5 mm. These screws can only

be used on-axis Variable Angle Locking plate 2.0 holes accept:

Variable Angle Locking screwsB2.0 mm Cortex screwsB2.0 mm Locking screwsB2.0 mm. These screws can only be

used on-axis Variable Angle Locking screws can be angled anywhere

within a 30 cone Cortex screwsB1.5 mm and 2.0 mm can be used in

the plate positioning slots, if present, for traditional compression and fixation

Locking Technology

Locking plates 1.3 feature locking, coaxial holes. Fully threaded locking holes provide threaded locking between the plate and the locking screw to create a fixed-angle construct

Locking plate 1.3 holes accept: Locking screwsB1.3 mm Cortex screwsB1.3 mm


SYSTEM FEATURES

Variable Angle Locking Hand System Overview

Features BenefitsExtensive range of implant options Accommodates a variety of fractures and patient sizes

Anatomically contoured plates Designed with contour to adapt to bony anatomy

Plates designed for lateral and direct dorsal application

Accommodates plate placement to help avoid tendon insertion points

Low-profile, anatomically precontoured plates Designed to reduce soft tissue irritation

Recessed screw heads Designed to sit flush with the plate surface

Variable Angle Locking Technology Offers screw placement options in a variety of fragment patterns and around the joint

Provides fixed angle stability for metaphyseal and osteopenic bone

Elongated plate holes Facilitate plate positioning

Modular, color-coded system Aids in clear identification of instruments for Operating Room staff and Central Processing

Facilitates proper instrumentation usage by size

Comprehensive instrumentation Aids surgeon in all aspects of procedure: plate adaption, provisional fixation, and bone preparation

Implants offered in both stainless steel and titanium Allows options for surgeon preference and patient need

T4 and T6 self-retaining screwdriver shafts Aid in screw handling, measuring, and delivery

Hex coupling screwdriver handle Ergonomic connection mechanism in a handle design that disassembles for cleaning

Reduction Forceps Aids reduction and lag screw application via forceps

Plate Holding Forceps Holds plate intraoperatively

1

4

2

3

4_Priciples_03.pdf 1 05.07.12 12:08

4 DePuy Synthes Expert Lateral Femoral Nail Surgical Technique

AO PRINCIPLES

In 1958, the AO formulated four basic principles, which have become the guidelines for internal fixation1, 2.

1 Mller ME, M Allgwer, R Schneider, H Willenegger. Manual of Internal Fixation. 3rd ed. Berlin Heidelberg New York: Springer. 1991.

2 Redi TP, RE Buckley, CG Moran. AO Principles of Fracture Management. 2nd ed. Stuttgart, New York: Thieme. 2007.

Anatomic reductionFracture reduction and fixation to restore anatomical relationships.

Early, active mobilizationEarly and safe mobilization and rehabilitation of the injured part and the patient as a whole.

Stable fixationFracture fixation providing abso-lute or relative stability, as required by the patient, the injury, and the personality of the fracture.

Preservation of blood supplyPreservation of the blood supply to soft tissues and bone by gentle reduction techniques and careful handling.


AO PRINCIPLES

In 1958, the AO formulated four basic principles, which have become the guidelines for internal fixation.1, 2

Those principles, as applied to the Variable Angle Locking Hand System, are:

Anatomic reductionFracture reduction and fixation to restore anatomical relationships.

Early, active mobilizationEarly and safe mobilization and rehabilitation of the injured part and the patient as a whole.

Stable fixationFracture fixation providing absolute or relative stability, as required by the patient, the injury, and the personality of the fracture.

Preservation of blood supplyPreservation of the blood supply to soft tissues and bone by gentle reduction techniques and careful handling.

1. Mller ME, Allgwer M, Schneider R, Willenegger H. Manual of Internal Fixation. 3rd ed. Berlin, Heidelberg, New York: Springer; 1991.

2. Redi TP, RE Buckley, CG Moran. AO Principles of Fracture Management. 2nd ed. Stuttgart, New York: Thieme; 2007.


Intended Use Variable Angle Locking Hand System Implants are intended for temporary fixation, correction or stabi-lization of bones in anatomical region of the hand.

Indications The Variable Angle Locking Hand System is indicated for the treatment of fractures, deformities and degenerative diseases in the hand.

Precaution: When using this system to treat skeletally immature patients, physiological status of the physes and individual stature of the patient should be assessed before considering treatment options as damage to the physes may occur, leading to potential growth arrest.

INTENDED USE AND INDICATIONS


FEATURED PLATES AND TECHNIQUE HIGHLIGHTS

The plates contained in this section are featured im-plants of the DePuySynthes Variable Angle Locking Hand System. Refer to the product information section for a complete list of all plate configurations offered as part of this system.

Phalangeal Head Plate

Designed with an anatomic contour and hole configuration to facilitate lateral fixation of fractures of the middle and proximal phalangeal head. Elongated hole for adjustment of plate position Ulnar or radial plate placement Curved plate designed to follow the natural curve of

the phalanx Screw configuration in the head is designed to span

the attachment of the collateral ligament Available in Right and Left orientations Designed for periarticular fractures and articular

fractures of the distal phalanx

Available sizes: Left Right1.3 mm 02.130.157 02.130.156 04.130.157 04.130.1561.5 mm 02.130.257 02.130.256 04.130.257 04.130.256

02 = Stainless Steel04 = Titanium

Left

Right

Surgical Approach

Ulnar Radial

Right Hand

Right Plate Left Plate

Left Hand

Left Plate Right Plate

2

3

4

1


Featured Plates and Technique Highlights

When implanting this plate, the following screw orderplacement is suggested. Place a cortex screw in the elongated hole (1), leaving

the screw slightly loose. Screw placement is at the midaxial line. Place plate prior to the K-wire so that the cortex screw can be positioned at the midaxial line

Provisionally fix the condyles. Place a K-wire in the center of the condyle, so the wire is located between the two distal holes (2). The K-wire should be placed in the center of the axis of the joint. K-wire placement is relative to the fan-shaped, central collateral ligament. Note that the footprint of the ligament is larger than the center of the axis. Make small adjustments to K-wire placement to avoid intra-articular placement of screws, while still creating a stable construct. Variations in K-wire placement are at surgeons discretion, considering periarticular tissue and fracture size. For Plates 1.3, use a K-wireB0.6 mm. For plates 1.5, use a K-wireB0.8 mm

Adjust the plate along the bone shaft, as necessary, so that the K-wire abuts the plate. Tighten the cortex screw in the elongated hole

Place a screw in most distal hole (3) Place screw in most volar hole (4) Confirm placement and depth of screws under

radiographic imaging Place remaining screws in the head and plate shaft,

depending on fracture pattern

Refer to surgical technique section for general plate andscrew application techniques where this suggested screw insertion order can be applied.

1

2


Phalangeal Base Plate

Designed with an anatomic contour and hole configuration to facilitate fixation of fractures at the base of the middle and proximal phalanx. Elongated hole for adjustment of plate position Lateral or dorsal placement Designed for metaphyseal transverse, oblique, or

comminuted fractures of the phalanx

When implanting this plate, the following screw order placement is suggested. Place cortex screw in elongated hole (1), leaving screw

slightly loose. Check alignment and adjust plate as necessary

Tighten screw in the elongated hole. Place a Variable Angle Locking Screw in one of the

head holes (2). For plates 1.3, place a locking screw. Confirm screw placement and depth under radiographic imaging

Place remaining screws in the head and plate shaft as needed, depending on fracture pattern

Refer to surgical technique section for general plate and screw application techniques where this suggested order can be applied.

Available sizes:1.3 mm 1.5 mm 2.0 mm02.130.154 02.130.254 02.130.35404.130.154 04.130.254 04.130.354


2

1



Condylar Plate

Straight plate with hole configuration designed to facilitate fixation of the middle and proximal phalanx, and the metacarpals. Elongated hole for adjustment of plate position Lateral or dorsal placement Designed for metaphyseal transverse, oblique, or

comminuted fractures of the phalanx and metacarpals

Position the head of the plate on the condyles.

When implanting this plate, the following screw order placement is suggested. Place a cortex screw in the elongated hole (1), leaving

screw slightly loose. Check alignment and adjust plate, as necessary.

Tighten the screw in the elongated hole. Place a Variable Angle Locking screw in one of the head holes (2). Confirm screw placement and length using radiographic imaging.

Place remaining screws in the head and plate shaft as needed, depending on fracture pattern


Available sizes:1.5 mm 2.0 mm02.130.255 02.130.35504.130.255 04.130.355


3

1

2


Metacarpal I Plate, Dorsal

Designed with an anatomic contour and hole configuration to facilitate fixation in fractures of the base of MC I. Elongated hole for adjustment of plate position Dorsal placement on MC I with the wide end of the

plate placed proximally Three K-wire holesB1.0 mm accept K-wiresB1.0 mm

or smaller, for provisional fixation 4 variable angle screw holes in head designed to

facilitate capture of fracture fragments Variable Angle Locking Plate 1.5 has higher strength

than a non-locking straight plate 2.0 mm*

Position plate on the metacarpal. During plate place-ment, consider the curve in the base of the metacarpal.

Place a K-wire in any of the three K-wire holes, if needed, to hold the plate in place and obtain provisional fixation of the fragments around the joint (1).

When implanting this plate, the following screw order placement is suggested: Place cortex screw in the elongated hole (2), leaving

the screw slightly loose. Adjust plate position, as necessary. Tighten cortex screw in the elongated hole.

Place a Variable Angle Locking Screw in the most proximal, metaphyseal head hole (3). The screw in the most proximal head hole is placed first since it is clos-est to the joint. Confirm screw placement and length under radiographic imaging.

Place remaining screws in the head and plate shaft as needed, depending on the fracture pattern


* Benchtop testing may not be indicative of clinical performance. Testing on file at DePuySynthes Companies. Testing was completed comparing the Metacarpal I Plate 1.5, Dorsal to the DePuySynthes non-locking straight plate 2.0 mm.

Available sizes:1.5 mm 2.0 mm02.130.263 02.130.363 02 = Stainless Steel04.130.263 04.130.363 04 = Titanium

Proximal Distal

2 2

1 1

2 2



Metacarpal I Plate, Lateral

Designed with a shape and hole configuration to facili-tate fixation in MC I fractures. This plate is designed to be contoured to fit the dorsal and radial periarticular sur-faces. Elongated hole for adjustment of plate position.

Elongated hole is positioned on the shaft Designed for palmar approach to MC I Lateral placement on MC I (radiopalmar) Plate adaptation is recommended to ensure correct fit

of plate to the bone (see technique section related to plate contouring)

Available in left and right orientations Y-shape with contourable arms to fit varying anatomy

and address fracture fragments Designed for T- or Y-shaped fractures in the sagittal

plane and comminuted intra-articular fractures of the base of the first metarcarpal.

Placement of the plate is fracture-dependent. When implanting this plate, the following screw order and placement is suggested: Ensure plate is contoured to fit anatomy, prior to

implantation. The more contoured arm of the plate is positioned so that it wraps around the bone palmarly. This contoured arm follows the curve of the shaft of the plate.

Place a cortex screw in the elongated hole (1), leaving the screw slightly loose. Adjust plate position, as necessary. Tighten cortex screw in the elongated hole.

Place a Variable Angle Locking screw in the arms of the plate (2). Confirm screw placement and length under radiographic imaging.

Place remaining screws in the plate, depending on fracture pattern.


Available size:1.5 mm Left Right 02.130.265 02.130.264 04.130.265 04.130.264

02 = Stainless Steel 04 = Titanium

Left Right

2

1

3


Metacarpal Neck Plate

Designed with an anatomic contour and hole configuration to facilitate fixation of the head and neck of the metacarpals. Elongated hole for adjustment of plate position MC V: ulnar placement MC II-IV: dorsolateral placement K-wireB1.0 mm hole accepts K-wiresB1.0 mm or

smaller, for provisional fixation 4 diverging screws for secure fixation Designed for unstable subcapital and comminuted

head and neck fractures of the metacarpals

When implanting this plate, the following screw order placement is suggested: Place a cortex screw in the elongated hole (1), leaving

the screw slightly loose. Adjust plate position, as necessary. Tighten cortex screw in the elongated hole

Additionally, a K-wire can be placed in the K-wire hole (2) in the distal portion of the plate to hold the plate in place, as necessary

Place a Variable Angle Locking Screw in the either of the most distal holes of the plate head (3). Avoid wire and screw interference when placing screws in a variable an-gle hole. If necessary, the K-wire can be bent slightly to facilitate placement of the Variable Angle Drill Guide into a plate hole in the head of the plate

Available size:1.5 mm 02.130.268 02 = Stainless Steel04.130.268 04 = Titanium


Confirm screw placement and length under radiographic imaging

Place remaining screws in the plate, depending on fracture pattern. Fracture pattern will dictate the order of screw placement



Variable Angle Screws at nominal angle in head of plate.

Variable Angle Screws at 15 angulation (distally) in head of plate.

1

2


Rotation Correction Plate

Designed with an anatomic contour and hole configuration to facilitate fixation of the metacarpals and phalanges. Elongated transverse hole for intraoperative

adjustment of the reduction, including correction of the fragment rotation of the bone, if necessary. Elongated hole allows 2.5 mm of travel

Design of the plate head facilitates contouring to the anatomy of the condyles

Designed for fractures and osteotomies of the metacarpals and phalanges

When implanting this plate, the following screw order placement is suggested: Position the plate with the T-shaped section of the

plate near the joint Insert 2 Variable Angle Locking Screws into the

T-shaped section of the plate (1), ensuring that the elongated hole (2) is on the side of the osteotomy away from the joint, near a section of intact bone. Confirm screw placement and length under radiographic imaging

Adjust the position of the bone Place a cortex screw into the elongated transverse

hole (2), leaving the screw loose. Release and tighten the cortex screw while adjusting plate position, as necessary

Check result of repositioning with the wrist at maximum extension. Tighten cortex screw

Place remaining screws distal or proximal to the elongated transverse hole. Confirm screw placement and depth using radiographic imaging


2

1


Rotation Correction Fracture Plate

Designed for indirect reduction techniques where bridging or in-situ reduction is desired. Allows adjustment of rotation and angulation before

fixed angle construct is applied. Consistent with AO indirect reduction techniques of external fixation1,2

Two elongated holes for intra-operative correction in 2 planes

Dorsal placement Staggered shaft Designed for crushed, multifragmented, and/or

periarticular fractures of the metacarpals and phalanges When implanting this plate, the following screw order placement is suggested: Insert a cortex screw into the head of the plate (1) into

the condyle, ensuring that the elongated hole (2) is on the side of the osteotomy away from the joint, near a section of intact bone. Provisional fixation in either adjacent hole may be helpful

Correct the position of the bone. Place a cortex screw in the elongated transverse hole (2)

Continue to adjust the position of the bone, as necessary Check result of repositioning Place remaining screws distal or proximal to the

elongated transverse hole



1. Mller ME, Allgwer M, Schneider R, Willenegger H. Manual of Internal Fixation. 3rd ed. Berlin, Heidelberg, New York: Springer; 1991.

2. Redi TP, RE Buckley, CG Moran. AO Principles of Fracture Management. 2nd ed. Stuttgart, New York: Thieme; 2007.


SCREWS IN THE SYSTEM

Screws withB1.3 mm

Locking Screws 1.3 mm Only for on-axis insertion in the locking holes Threaded, conical head locks securely into the

locking hole Self-retaining,T4 Stardrive recess Self-tapping tip facilitates insertion

Cortex Screws 1.3 mm Can be used in locking holes to compress the plate

to the bone Self-retaining,T4 Stardrive recess Self-tapping tip facilitates insertion

Screws withB1.5 mm

Variable Angle Locking Screws 1.5 mm Threaded, rounded head locks securely into the

Variable Angle Locking hole Purple, color-coded head to easily distinguish as

Variable Angle Locking Screw Self-retaining, T4 Stardrive recess Blunt self-tapping tip

Cortex Screws 1.5 mm Can be used in the Variable Angle Locking holes to

compress the plate to the bone Self-retaining, T4 Stardrive recess Self-tapping tip facilitates insertion

Also Available Locking Screws, Stardrive,B1.5 mm only used

on-axis Compatible with Variable Angle Locking Plate 1.5 mm


Screws withB2.0 mm

Variable Angle Locking Screws 2.0 mm Threaded, rounded conical head locks securely into

the locking hole Purple, color-coded head to easily distinguish as a

Variable Angle Locking Screw Self-retaining, T6 Stardrive recess Blunt, self-tapping tip

Cortex Screws 2.0 mm Can be used in the Variable Angle Locking holes to

compress the plate to the bone Self-retaining, T6 Stardrive recess Self-tapping tip facilitates insertion

Also Available Locking Screws, Stardrive,B2.0 mm only used

on-axis Compatible with Variable Angle Locking Plate 2.0 mm


Reduction Forceps for Cortex Screws (03.130.291)

This instrument is designed to hold reduced metacarpal and phalangeal bone fragments in place, while allowing insertion of a lag screw through the barrel of the for-ceps. Colors on the drill sleeves indicate the screw size and color bands indicate the threaded and gliding hole.

Plate Holding Forceps with Pointed Ball Tip (03.130.280)

The plate holding forceps are designed to hold the plate in the desired position against the bone. The ball on the upper portion of the jaws inserts

through the plate hole to the bone, and the lower arm is inserted beneath the soft tissue against the underside of the bone

The forceps can then be closed to the desired tightness to hold the plate, and is designed to remain in place after the handles are released

FEATURED INSTRUMENTS


Plate Holder (03.130.130)

The plate holder is designed to hold the plates. The arms are squeezed together and inserted into a

single plate hole. Once the arms are released, they hold the plate via tension

The arms of the plate holders can also be placed in two adjacent holes

The forceps can also be used to hold the outside edges of the plate. If used to hold the outside of the plate, releasing the arms of the holder will allow the plate to disengage.


Cutting Pliers, In-Line, for Locking Plates 1.3 and VA Locking Plates 1.5 and 2.0 (03.130.270)

The cutting pliers, in-line for plates are designed to cut plates with straight shafts within the Variable Angle Locking Hand System. Variable Angle Locking and Locking Plate holes are

inserted over the insertion posts to hold the plate in place

A rasp for manual deburring feature is provided on the plate cutter head, if deburring is needed after cutting

Cutting Pliers for Locking Plates 1.3 and VA Locking Plates 1.5 and 2.0 (03.130.271)

The cutting pliers for locking plates are designed to cut all plates within the variable Angle Locking Hand System. A rasp for manual deburring is provided on the plate

cutter head, if deburring is needed after cutting

Featured Instruments


Bending Pliers for Locking Plates 1.3 and VA Locking Plates 1.5 and 2.0 (03.130.260, 03.130.261)

Bending pliers facilitate additional contouring of the plates, if necessary.

Bending Pins for Locking Plates 1.3 (03.130.140)

Bending Pins facilitate additional contouring of 1.3 mm plates, if necessary.


Handle for Screwdriver with Hexagonal Coupling (03.130.005)

The design of the handle reduces the likelihood of rolling on a flat surface.

The hex coupling provides a one-step, reliable connec-tion when inserting the screwdriver shaft.

The handle disassembles into three pieces for cleaning and sterilization. The three parts include the hex cou-pling with spring, the shaft, and the handle.

Stardrive Screwdriver Shafts (03.130.010, 03.130.020)

Self-retaining screwdrivers aid in screw handling, measuring, and delivery. Screws withB1.3 and 1.5 mm feature a T4 Stardrive recess. The tip of the T4 screwdriver is gold-colored. Screws withB2.0 mm feature a T6 Stardrive recess.



Nominal Angle (Coaxial)

Nominal angle technique using the fixed-angle end marked coaxial.

Variable Angle

Variable angle technique using the cone-shaped end.

Variable Angle Drill Guidecoaxial and conical (03.130.220, 03.130.320)

The VA Drill Guide, coaxial and conical, is designed for variable angle technique (cone-shaped end) and nominal angle technique (coaxial).




Variable Angle

Variable angle technique using the variable angle end, which allows freehand angulation of the drill bit.


Variable Angle Drill Guidecoaxial and freehand useable (03.130.221, 03.130.321)

The VA Drill Guide, coaxial and freehand useable is designed for variable angle technique and nominal angle technique (coaxial).


1 Preparation

Complete preoperative radiographic assessment and preoperative planning.

Select the implant according to the fracture pattern and anatomy of the bone.

Note: Ensure the proper plate selection is available, including L (left) or R (right) plates. Left plates are designed for the left hand. Right plates are designed for the right hand. For clarification on right and left Phalangeal Head Plate application, see information on page 7.

PREOPERATIVE PLANNING AND REDUCTION


Preoperative Planning and Reduction

2Reduce Fracture

Instruments

292.060/492.060 Kirschner WireB0.6 mm with trocar tip, length 70 mm, (stainless steel or titanium)

292.080/492.080 Kirschner WireB0.8 mm with trocar tip, length 70 mm (stainless steel or titanium)



Reduce fracture under imaging. The reduction method will depend on patient anatomy and fracture pattern.

Optional instrument

03.130.291 Reduction Forceps for Cortex Screws B1.3 to 2.0 mm, soft lock, length 140 mm


LAG SCREW INSERTION (OPTIONAL)LAG SCREW INSERTION REDUCTION FORCEPS

1 Select a Drill Sleeve and Drill Bit

Lag screws may be inserted using the Reduction Forceps for Cortex ScrewsB1.3 to 2.0 mm (03.130.291). The associated drill sleeves and drill bits use a color-coded stripe system. The colors on the drill sleeves and drill bits correspond to the screw size. A single stripe indicates that the drill sleeve or drill bit is used for a threaded hole (pilot hole); a double stripe indicates that the drill sleeve or drill bit is used for a gliding hole.

Screw Size

Color Coding for

Instruments

Drill Guide Insert for

Threaded Hole

Drill Bit for Threaded Hole

(One Color Stripe)*

Drill Guide Insert for

Gliding Hole

Drill Bit for Gliding Hole

(Two Color Stripes)*

1.3 mm Yellow

1.0 mm03.130.292

1.0 mm 1.3 mm03.130.294

1.3 mm

1.5 mm Red

1.1 mm03.130.293

1.1 mm 1.5 mm03.130.295

1.5 mm

2.0 mm Blue

1.5 mm03.130.296

1.5 mm 2.0 mm03.130.297

2.0 mm

* Drill bits are available with various couplings, including Mini Quick Coupling, Jacobs Chuck, and J-Latch.


2Assemble Drill Guide Insert To Forceps

Press the drill guide insert into the barrel of the reduction forceps so that the guide is fully seated and a click is felt.

3Attach The Reduction Forceps To The Bone

Once in place, close the reduction forceps to the desired tightness. The forceps is designed to remain in place after the handles are released.

Lag Screw Insertion (Optional)Lag Screw Insertion Reduction Forceps


4Drill Threaded and Gliding Hole

Gliding Hole Drill the near cortex, so that the thread of the screw does not obtain purchase, using a drill bit for the gliding hole and the corresponding drill guide insert.

Drill so that the lag screw is perpendicular to the fracture plane.

An alternative technique is to drill for the gliding hole first and then drill for the threaded hole.

Threaded HoleDrill the far fragment using a drill bit for the threaded hole and the corresponding drill guide insert.

Gliding Hole

Threaded Hole


5Countersink (Optional)

Remove the drill guide insert from the forceps. Attach the Countersink for ScrewsB1.3 to 2.0 mm (03.130.215) to the handle for screwdriver. Countersink, if desired.

6Measure

Insert the Depth Gauge for ScrewsB1.3 to 2.0 mm (03.130.250) through the barrel of the forceps, to determine the screw length needed. The depth gauge is designed for one-handed use.



The black line indicates the screw length.

Optional Technique Use the scale on the back of the depth gauge to mea-sure for screw length.

Note: the depth gauge consists of 2 pieces and is designed to be disassembled for cleaning. Slide the tip of the hook so it is fully inside the black outer body. Press the tab on the back of the sliding hook and remove it from the black outer body.


7Insert Cortex Screw

Instruments

03.130.010 Screwdriver Shaft Stardrive 1.3/1.5, T4, self-holding, for Hexagonal Coupling

03.130.020 Screwdriver Shaft Stardrive 2.0, T6, self-holding, for Hexagonal Coupling

Assemble the screwdriver shaft to the handle for screwdriver.

For 1.3 mm and 1.5 mm screws, use the Screwdriver Shaft Stardrive 1.3/1.5, T4 (03.130.010, with yellow and red bands). The tip of the T4 screwdriver is coated in gold-color.

For 2.0 mm screws, use the Screwdriver Shaft Stardrive 2.0, T6 screwdriver shaft (03.130.020, with blue band).

The screwdriver and screws are designed to be self holding.To attach the screw to the screwdriver, position the screwdriver directly in line with the screw with no tilting.

Ensure that the screwdriver tip engages the star-shaped lobes of the recess in the screw. It may be necessary to rotate the screwdriver up to a quarter turn to fully align the lobes of the screwdriver tip with the lobes of the screw recess. In addition, a tactile sensation may be noticed when the tip of the screwdriver shaft is fully aligned with the screw recess. Apply firm axial pressure downwards to ensure that the screw is fully seated before removing the screw from the implant module.

Using the screwdriver, place the screw on the scale of the implant module, to confirm the length of the screw.

Insert the screw through the barrel of the reduction forceps.

Confirm screw placement under radiographic imaging. Once the screw has been inserted, remove the forceps from the bone.

Note: Prior to sterilization of the reduction forceps, soft lock, add one drop of DePuySynthes Autoclavable Oil (519.970) to instrument joints and ratchet mechanisms.



Instruments

03.130.125 Double Drill Guide 1.3/1.0



For cortex screwsB1.3, 1.5 and 2.0 mm used as independent lag screws, use a double-ended drill guide and corresponding drill bit. Drill bits and drill guides are color-coded. Drill bits are available with several different couplings (see item listing). Etch lines on drill bits are spaced 5 mm apart.

A K-wire may be used through the double drill guide.

LAG SCREW INSERTION DOUBLE DRILL GUIDE (OPTIONAL)

Screw Size Color Coding for

Instruments

Double Drill Guide Drill Bit For Threaded Hole

(One Color Stripe)*

Drill Bit for Gliding Hole

(Two Color Stripes)*

1.3 mm Yellow

03.130.125 1.0 mm 1.3 mm

1.5 mm Red03.130.225 1.1 mm 1.5 mm

2.0 mm Blue03.130.325 1.5 mm

2.0 mm

* Drill bits are available with various couplings, including Mini Quick Coupling, K-wire, and J-Latch.


Lag Screw Insertion Double Drill Guide (Optional)

For cortex screwsB1.0 used as independent lag screws, use a drill bitB0.8 mm (green band) and drill bitB1.0 mm. Insert the screws using the Screwdriver Shaft 1.0, cruciform, with holding sleeve, with Hexagonal Coupling (314.482).

Instruments

03.130.000 Drill BitB0.8 mm, length 64/33 mm, for Pilot Hole, for Jacobs Chuck

316.494 Drill BitB0.8 mm, length 56/16 mm, 2-flute, for J-Latch Coupling

316.385 Drill BitB0.8 mm, length 40/16 mm, 2-flute, for Mini Quick Coupling

314.482 Screwdriver Shaft 1.0, cruciform, with holding sleeve, with Hex Coupling


PREPARE AND INSERT PLATE

Trial Implants (Optional)

To determine plate type and size intra-operatively, select a trial implant. Trial implants are available for most plates in the system (see complete list on pages 6972).

Place the trial implant on the bone.

Trial Implants are etched with the position of screw holes. K-wire holes are located on the trial implant be-tween the screw holes for provisional fixation of the trial implant. The trial implants include an elongated slot or round hole, which can be used with the Plate Holding Forceps (03.130.280) for placement.

After coupling, remove trial implant and K-wires.

Warning: Do not bend or cut trial implants. Do not implant trial implants.


Prepare and Insert Plate

1Trim Plate

Instrument

03.130.271 Cutting Pliers for Locking Plates 1.3 and VA Locking Plates 1.5/2.0

If desired, plate cutting pliers can be used to adjust the length of the plate. The Cutting Pliers (03.130.271) are designed to cut all plates within the Variable Angle Locking Hand System.

Note: To prevent sharp edges from causing soft tissue irritation, place the plate top side up on the cutters to ensure any sharp edges will angle to-wards the underside of the plate.

Trim the plate to the desired length using the cutting pliers, and remove any burr by using the rasp on the side of the cutting pliers.

The cutting pliers create a straight cut. Remove any burr by using the rasp on the side of the cutting pliers.


Optional instrument

03.130.270 Cutting Pliers, In-Line, for Locking Plates 1.3 and VA Locking Plates 1.5/2.0

The Cutting Pliers, In-Line (03.130.270) are designed to cut plates with straight shafts within the Variable Angle Locking Hand System.

Note: When using the cutting pliers, in-line, insert the plate top side up in its respective color coded area on the cutting pliers. This is to ensure that the plate holes are protected during cutting. Insert the plate so that the section of the plate to be implanted is located on the side that is color-coded. Ensure that the plate is correctly inserted on the post.

These cutting pliers are designed to be used to cut straight shafts of plates within the Variable Angle Lock-ing Hand System.

Note: The cutting pliers are designed with 2 silicone inserts in the jaws to hold the cut segment of the plate after cutting. The cutting pliers, in-line are de-signed with 1 silicone insert. Remove the silicone insert(s) prior to cleaning and sterilization.

The cutting pliers, in-line, create a cut with a rounded profile. Remove any burr by using the rasp on the side of the cutting pliers.

Cut portion of plate



2Contour Plate

If necessary, contour the plate to fit the patients anat-omy.

Instruments

03.130.260 Bending Pliers for Locking Plates 1.3 and VA Locking Plates 1.5/2.0, right

03.130.261 Bending Pliers for Locking Plates 1.3 and VA Locking Plates 1.5/2.0, left

03.130.140 Bending Pin for Locking Plates 1.3, with thread

Bend using adjacent holes in the plate. Orient the bending pliers so the side etched UP is facing up, with the top of the plate also facing up.

Precaution: Reverse bending or use of the incorrect instrumentation for bending may weaken the plate and lead to premature plate failure (e.g. breakage). Do not bend the plate beyond what is required to match the anatomy.


Optional

The Bending Pin for Locking Plates 1.3 (03.130.140) are designed to be used with the 1.3 mm locking plates.

Bend adjacent holes in the plates.

Precaution: Avoid reverse bends and sharp bends (sharp bends include a single out-of-plane bend between two adjacent holes of >30). Reverse or sharp bends may weaken the plate and lead to premature plate failure.


For more information, refer to the Featured Instrument section.


Optional instrument

03.130.280 Plate Holding Forceps with pointed ball tip

As an alternative, the plate holding forceps with pointed ball tip may be used to hold the plate to the bone. Insert the ball portion through a plate hole to the bone. The curved arm wraps around the underside of the bone through the incision.

Close the forceps to the desired tightness to hold the plate. The forceps is designed to remain in place after the handles are released.

Precaution: When using the plate holding forceps with pointed ball tip, avoid the tendons and avoid applying excessive pressure.

Note: Prior to sterilization of the plate holding forceps with pointed ball tip, add one drop of DePuySynthes Autoclavable Oil (519.970) to instrument joints and ratchet mechanisms.

3 Position Plate

Instruments

292.060/ Kirschner WireB0.6 mm with trocar tip, 492.060 length 70 mm (stainless steel and titanium)

292.080/ Kirschner WireB0.8 mm with trocar tip, 492.080 length 70 mm (stainless steel or titanium)

292.100/ Kirschner WireB1.0 mm with trocar tip, 492.100 length 150 mm (stainless steel or titanium)

Position the plate over the reduced fracture using the preferred positioning method. Either K-wires or forceps may be used to hold the plate in place. K-wires can be used in the plate K-wire holes, if present.


4 Determine Screw Type

Depending on the individual case, cortex screws or Variable Angle Locking/Locking Screws may be inserted. Locking or cortex screws can be used in any of the screw holes, with the exception of the nonthreaded elongated hole, if present.

The elongated hole is designed for adjustment of plate position. The elongated hole accepts cortex screws only. Leave the cortex screw slightly loose in the elongated hole while adjusting plate position, as necessary. Tighten the cortex screw once plate placement has been con-firmed.

If a combination of locking and cortex screws is planned, a cortex screw should be inserted first to pull the plate to the bone. If a locking screw is inserted first, ensure that the plate is held securely to the bone, to avoid spinning the plate as the screw is locked in place.


5Drill

Instruments

For Screws with B1.3 mm


03.130.101 Drill BitB1.0 mm, length 61/31 mm, for Pilot Hole, for J-Latch Coupling

03.130.102 Drill BitB1.0 mm, length 61/31 mm, for Pilot Hole, for Mini Quick Coupling









Select a drill bit based on the size of the screw. Drill bits are color-coded to the size of the associated screw.

Note: The fracture pattern will dictate the optimal screw placement.

Fracture pattern will determine the order of screw insertion. In all cases, make sure the plate is in the correct position and flush with the bone. If placing a plate on the con-dyle, be cognizant of reducing and restoring the articular surface.


Screw Size Drill Bit Size/Color Code 1.3 mm 1.0 mm Yellow

1.5 mm 1.1 mm Red

2.0 mm 1.5 mm Blue




Variable Angle

Variable angle technique using the cone-shaped end.

6Select a Drill Guide and Drilling Technique

VA Drill Guide, coaxial and conical (03.130.220, 03.130.320)

Variable Angle Locking Screws can be inserted using 2 different techniques, depending on which end of the drill guide is used:

Fully insert the variable angle end of the drill guide into the Variable Angle Locking hole. When drilling, the tip of the drill guide should remain fully seated in the hole

Drill the hole with the drill bit at the desired angle within the cone by positioning the drill bit.

Precaution: When using the variable angle end of the guide, it is important to not angulate more than 15 from the central axis of the screw hole. Overan-gulation could result in difficulty locking the screw.

Fully insert the coaxial end of the drill guide into the Variable Angle Locking hole and drill.

Verify the drill bit angle and depth under radiographic imaging to ensure the desired angle has been achieved.

If necessary, drill at a different angle and verify again under imaging.

Precaution: Avoid redrilling, especially in osteopenic bone.


Nominal Angle


Fully insert the coaxial end of the drill guide into the Variable Angle Locking hole and drill.

Variable Angle

Variable angle technique using the variable angle.

Fully insert the variable angle end of the drill guide into the Variable Angle Locking hole.

Drill the hole with the drill bit at the desired angle by positioning the drill guide in the hole.

Precaution: When using the variable angle end of the guide, it is important to not angulate more than 15 from the central axis of the screw hole. Over angu-lation could result in difficulty locking the screw.


Drill for Variable Angle Screws Freehand

VA Drill Guide, coaxial and freehand useable (03.130.221, 03.130.321)

Variable Angle Locking Screws can be inserted using 2 different techniques, depending on which end of the drill guide is used:

Verify the drill bit angle and depth under radiographic imaging to ensure the desired angle has been achieved.

If necessary, drill at a different angle and verify again under imaging. Avoid redrilling, especially in osteopenic bone.


A Drill Sleeve 1.3, with thread, for Drill BitsB1.0 mm (03.130.120) is available for use with only the plates 1.3.

The drill guide allows drilling in the nominal position in the locking hole.

Use a Double Drill Guide (03.130.125, 03.130.225, or 03.130.325) to drill for cortex screws through the plate.


7 Determine Screw Length

Use the Depth Gauge for ScrewsB1.3 to 2.0 mm (03.130.250) to determine screw length. Screw length is indicated by the black line.


See pages 3233 for additional technique information for the depth gauge.


8Insert Screw

Instruments



03.130.005 Handle for Screwdriver, with Hexagonal Coupling

Assemble the screwdriver shaft to the handle for screwdriver.

ScrewsB1.3 and 1.5 mm are inserted with a screw-driver shaft Stardrive T4 (yellow and red bands). The tip of the screwdriver is coated in gold-color.

ScrewsB2.0 mm are inserted with a screwdriver shaft Stardrive T6 (blue band).

The screwdriver shafts and screws are designed to be self holding. To attach the screw to the screwdriver, position the screwdriver directly in line with the screw, with no tilting.

Ensure that the screwdriver tip engages the star-shaped lobes of the recess in the screw. It may be necessary to rotate the screwdriver up to a quarter turn to fully align the lobes of the screwdriver tip with the lobes of the screw recess. In addition, a tactile sensation may be noticed when the tip of the screwdriver shaft is fully aligned with the screw recess. Apply firm axial pressure downwards to ensure that the screw is fully seated before removing the screw from the implant module.

Using the screwdriver, place the screw on the scale of the implant module, to confirm the length of the screw.

Insert screw.


Postoperative Treatment

Postoperative treatment with locking plates or Variable Angle Locking Plates does not differ from conventional internal fixation procedures.

When inserting screws, use a two-finger tightening technique.

For Variable Angle Locking and Locking Screws, confirm screw placement and length under radiographic imaging prior to final tightening.

For Variable Angle Locking and Locking Screws, screw insertion is complete when the screw is flush to the plate.

Confirm screw position and depth under radiographic imaging.

Precaution: Avoid penetrating the articular surface.

INSERT SCREW


If removal of the implant is necessary, the following instructions are suggested.

1Preoperative Planning

To ensure that the appropriate screw removal instru-ments are obtained, the surgeon should have the follow-ing information before implant removal: Implant type Time of implantation Material (steel, titanium) Recess geometry and dimension of screws Any visible damage to the implant (eg, broken

screw shaft)

2Clean Recess

Instrument

319.390 Sharp Hook, length 155 mm

Before removing screws, clean the screw recess. Free the screw recess from ingrown bone and tissue using the sharp hook to ensure the screwdriver can be fully inserted. Check the condition and the geometry of the recess of the exposed screwhead.

IMPLANT REMOVAL


3Implant Removal

Instruments

314.482 Screwdriver Shaft 1.0, cruciform, with holding sleeve, with Hexagonal Coupling




Optional set

01.900.020 Extraction Set for Standard Screws

To remove locking screws, first unlock all screws from the plate; then remove the screws completely from the bone.

The last screw removed should be a nonlocking screw on the shaft. This prevents the plate from spinning when locking screws are removed.

Note: To remove broken screws or screws with a damaged screw recess, please refer to the DePuySynthes Screw Extraction Set Application Notes for removal instructions.

Implant Removal


SUMMARY TABLE INSTRUMENTS

Gliding Hole

Threaded Hole

Screw Size

Cortex B 1.0 mm Cortex B 1.3 mm Cortex B 1.5 mm Cortex B 2.0 mm

Drill Bit

Gliding Hole(Two Stripes) 1.0 mm 1.3 mm 1.5 mm 2.0 mm

Threaded Hole (One Stripe) 0.8 mm 1.0 mm 1.1 mm 1.5 mm

Drill Guide

Double Drill Guide for

Cortex Screws n/a03.130.125

(1.3/1.0 mm)03.130.225(1.5/1.1 mm)

03.130.325(2.0/1.5 mm)

For Variable Angle Locking, Locking, or Cortex Screws through the plate

Cortex B 1.0 mm Locking or Cortex Screws B 1.3 mm

Variable Angle Locking or Cortex Screws B 1.5 mm

Variable Angle Locking or Cortex Screws B 2.0 mm

Drill Bit

n/a

1.0 mm 1.1 mm 1.5 mm

Drill Guide

Variable Angle Double Drill

Guide with Cone n/a

03.130.220(1.1 mm)

03.130.320(1.5 mm)

Variable Angle Double Drill

Guide Freehand

03.130.221(1.1 mm)

03.130.321(1.5 mm)

Threaded Drill Guide

n/a

03.130.120

n/a

Double Drill Guide for

Cortex Screws

n/a03.130.125

(1.3/1.0 mm)03.130.225 (1.5/1.1 mm)

03.130.325 (2.0/1.5 mm)

ScrewdriverCruciform 314.482 T4 Stardrive 03.130.010 T6 Stardrive 03.130.020

Depth Gauge 03.130.250


Locking Plates 1.3 316 Stainless Steel and TiCP Titanium*Plate Thickness: 0.75 mm

StainlessSteel Titanium

02.130.150 04.130.150 Locking Plate 1.3, 6 holes, straight, length 24 mm

02.130.151 04.130.151 Locking Plate 1.3, 12 holes, straight, length 48 mm

02.130.152 04.130.152 Locking T-Plate 1.3, head 3 holes, shaft 5 holes, length 26 mm

02.130.153 04.130.153 Locking Y-Plate 1.3, head 3 holes, shaft 5 holes, length 27 mm

02.130.154 04.130.154 Locking Phalangeal Base Plate 1.3, head 2 holes, shaft 5 holes, length 26 mm

02.130.156 04.130.156 Locking Phalangeal Head Plate 1.3, right, length 22 mm

02.130.157 04.130.157 Locking Phalangeal Head Plate 1.3, left, length 22 mm

02.130.158 04.130.158 Locking Strut Plate 1.3, 8 holes, oblique-angled, right, length 19 mm

02.130.159 04.130.159 Locking Strut Plate 1.3, 8 holes, oblique-angled, left, length 19 mm

02.130.161 04.130.161 Locking Web Plate 1.3, 14 holes, length 29 mm

PLATES

* Available nonsterile or sterile-packed. Add S to catalog number to order sterile product.


Variable Angle Locking Plates 1.5 316L Stainless Steel and TiCP Titanium* Plate Thickness: 1.0 mm


02.130.250 04.130.250 VA Locking Plate 1.5, 6 holes, straight, length 28 mm


02.130.252 04.130.252 VA Locking T-Plate 1.5, head 3 holes, shaft 7 holes, length 40 mm

02.130.253 04.130.253 VA Locking Y-Plate 1.5, head 3 holes, shaft 7 holes, length 42 mm

02.130.254 04.130.254 VA Locking Phalangeal Base Plate 1.5, head 2 holes, shaft 6 holes, length 36 mm

02.130.255 04.130.255 VA Locking Condylar Plate 1.5, head 2 holes, shaft 6 holes, length 36 mm

02.130.256 04.130.256 VA Locking Phalangeal Head Plate 1.5, right, length 26 mm

02.130.257 04.130.257 VA Locking Phalangeal Head Plate 1.5, left, length 26 mm

02.130.258 04.130.258 VA Locking Strut Plate 1.5, 8 holes, oblique-angled, right, length 23 mm

02.130.259 04.130.259 VA Locking Strut Plate 1.5, 8 holes, oblique-angled, left, length 23 mm

02.130.260 04.130.260 VA Locking Strut Plate 1.5, 12 holes, rectangular, length 36 mm

02.130.261 04.130.261 VA Locking Web Plate 1.5, 14 holes, length 33 mm





02.130.263 04.130.263 VA Locking Plate 1.5, for Metacarpal I, dorsal, length 29 mm

02.130.264 04.130.264 VA Locking Plate 1.5, for Metacarpal I, lateral, right

02.130.265 04.130.265 VA Locking Plate 1.5, for Metacarpal I, lateral, left

02.130.266 04.130.266 VA Locking Rotation Correction Plate 1.5, head 2 holes, shaft 6 holes, length 33 mm

02.130.267 04.130.267 VA Locking Rotation Correction Fracture Plate 1.5, length 32 mm

02.130.268 04.130.268 VA Locking Metacarpal Neck Plate 1.5, length 29 mm

Plates


Variable Angle Locking Plates 2.0316L Stainless Steel and TiCP Titanium*Plate Thickness: 1.3 mm




02.130.352 04.130.352 VA Locking T-Plate 2.0, head 3 holes, shaft 7 holes, length 50 mm

02.130.353 04.130.353 VA Locking Y-Plate 2.0, head 3 holes, shaft 7 holes, length 52 mm

02.130.354 04.130.354 VA Locking Phalangeal Base Plate 2.0, head 2 holes, shaft 6 holes, length 44 mm

02.130.355 04.130.355 VA Locking Condylar Plate 2.0, head 2 holes, shaft 6 holes, length 44 mm



02.130.363 04.130.363 VA Locking Plate 2.0, for Metacarpal I, dorsal, length 32 mm

02.130.366 04.130.366 VA Locking Rotation Correction Plate 2.0, 2 + 6 holes, length 41 mm

02.130.367 04.130.367 VA Locking Rotation Correction Fracture Plate 2.0, length 42 mm



SCREWS

Cortex ScrewsB1.0 mm, Self-Tapping, Cruciform* 316L Stainless Steel and TiCP Titanium

Stainless Steel Titanium Length (mm)

200.526 400.526 6

200.527 400.527 7

200.528 400.528 8

200.529 400.529 9

200.530 400.530 10

200.531 400.531 11

200.532 400.532 12

200.533 400.533 13

200.534 400.534 14



Cortex ScrewsB1.3 mm, Self-Tapping, T4 Stardrive Recess*316L Stainless Steel and Titanium Alloy**


02.130.004 04.130.004 4

02.130.005 04.130.005 5

02.130.006 04.130.006 6

02.130.007 04.130.007 7

02.130.008 04.130.008 8

02.130.009 04.130.009 9

02.130.010 04.130.010 10

02.130.011 04.130.011 11

02.130.012 04.130.012 12

02.130.013 04.130.013 13

02.130.014 04.130.014 14

02.130.015 04.130.015 15

02.130.016 04.130.016 16

02.130.018 04.130.018 18

Locking ScrewsB1.3 mm, Self-Tapping, T4 Stardrive Recess*316L Stainless Steel and Titanium Alloy**


02.130.104 04.130.104 4

02.130.105 04.130.105 5

02.130.106 04.130.106 6

02.130.107 04.130.107 7

02.130.108 04.130.108 8

02.130.109 04.130.109 9

02.130.110 04.130.110 10

02.130.111 04.130.111 11

02.130.112 04.130.112 12

02.130.113 04.130.113 13

02.130.114 04.130.114 14

02.130.115 04.130.115 15

02.130.116 04.130.116 16

02.130.118 04.130.118 18


** Ti-6Al-7Nb


Screws

Cortex ScrewsB1.5 mm, Self-Tapping, T4 Stardrive Recess* 316L Stainless Steel and Titanium Alloy**


02.214.104 04.214.104 4

02.214.105 04.214.105 5

02.214.106 04.214.106 6

02.214.107 04.214.107 7

02.214.108 04.214.108 8

02.214.109 04.214.109 9

02.214.110 04.214.110 10

02.214.111 04.214.111 11

02.214.112 04.214.112 12

02.214.113 04.214.113 13

02.214.114 04.214.114 14

02.214.115 04.214.115 15

02.214.116 04.214.116 16

02.214.118 04.214.118 18

02.214.120 04.214.120 20

02.214.122 04.214.122 22

02.214.124 04.214.124 24


** Ti-6Al-7Nb


Variable Angle Locking ScrewsB1.5 mm, Self-Tapping, T4 Stardrive Recess* 316L Stainless Steel and Titanium Alloy**


02.130.204 04.130.204 4

02.130.205 04.130.205 5

02.130.206 04.130.206 6

02.130.207 04.130.207 7

02.130.208 04.130.208 8

02.130.209 04.130.209 9

02.130.210 04.130.210 10

02.130.211 04.130.211 11

02.130.212 04.130.212 12

02.130.213 04.130.213 13

02.130.214 04.130.214 14

02.130.215 04.130.215 15

02.130.216 04.130.216 16

02.130.218 04.130.218 18

02.130.220 04.130.220 20

02.130.222 04.130.222 22

02.130.224 04.130.224 24


** Ti-6Al-7Nb


Cortex ScrewsB2.0 mm, Self-Tapping, T6 Stardrive Recess* 316L Stainless Steel and Titanium Alloy**


201.356 401.356 6

201.357 401.357 7

201.358 401.358 8

201.359 401.359 9

201.360 401.360 10

201.361 401.361 11

201.362 401.362 12

201.363 401.363 13

201.364 401.364 14

201.365 401.365 15

201.366 401.366 16

201.368 401.368 18

201.370 401.370 20

201.372 401.372 22

201.374 401.374 24

Screws

Variable Angle Locking ScrewsB2.0 mm, Self-Tapping, T6 Stardrive Recess*316L Stainless Steel and Titanium Alloy**


02.130.306 04.130.306 6

02.130.307 04.130.307 7

02.130.308 04.130.308 8

02.130.309 04.130.309 9

02.130.310 04.130.310 10

02.130.311 04.130.311 11

02.130.312 04.130.312 12

02.130.313 04.130.313 13

02.130.314 04.130.314 14

02.130.315 04.130.315 15

02.130.316 04.130.316 16

02.130.318 04.130.318 18

02.130.320 04.130.320 20

02.130.322 04.130.322 22

02.130.324 04.130.324 24


** Ti-6Al-7Nb


292.060.10 Kirschner WireB0.6 mm with trocar tip, length 70 mm, Stainless Steel, pack of 10 units





492.060 Kirschner WireB0.6 mm with trocar tip, length 70 mm, Titanium Alloy (TAV)





KIRSCHNER WIRES





03.130.110 Drill BitB1.3 mm, length 60/29 mm, for Gliding Hole, for Jacobs Chuck

03.130.111 Drill BitB1.3 mm, length 55/29 mm, for Gliding Hole, for J-Latch Coupling

03.130.112 Drill BitB1.3 mm, length 46/29 mm, for Gliding Hole, for Mini Quick Coupling




INSTRUMENTS


316.494 Drill BitB0.8 mm, length 56/16 mm, 2-flute, for J-Latch Coupling

316.385 Drill BitB0.8 mm, length 40/16 mm, 2-flute, for Mini Quick Coupling













314.482 Screwdriver Shaft1.0, cruciform, with holding sleeve, with Hexagonal Coupling


Instruments


03.130.120 Drill Sleeve 1.3, with thread, for Drill BitsB1.0 mm


03.130.220 VA Drill Guide, coaxial and conical, for Drill BitsB1.1 mm

03.130.221 VA Drill Guide, coaxial and freehand useable, for Drill BitsB1.1 mm


03.130.320 VA Drill Guide, coaxial and conical, for Drill BitsB1.5 mm

03.130.321 VA Drill Guide, coaxial and freehand useable, for Drill BitsB1.5 mm



03.130.250 Depth Gauge for ScrewsB1.3 to 2.0 mm, measuring range to 43 mm

03.130.215 Countersink for ScrewsB1.3 to 2.0 mm, for Hexagonal Coupling

03.130.260 Bending Pliers for Locking Plates 1.3 and VA Locking Plates 1.5/2.0, right

03.130.261 Bending Pliers for Locking Plates 1.3 and VA Locking Plates 1.5/2.0, left

03.130.270 Cutting Pliers, In-Line, for Locking Plates 1.3 and VA Locking Plates 1.5/2.0

03.130.271 Cutting Pliers for Locking Plates 1.3 and VA Locking Plates 1.5/2.0

03.130.277 Silicone Insert for Cutting Pliers, In-Line, 03.130.270

03.130.279 Silicone Insert for Cutting Pliers 03.130.271

03.130.130 Plate Holder


OPTIONAL INSTRUMENTS

03.130.292 Drill Guide Insert, yellow, for Drill Bits B 1.0 mm, for No. 03.130.291

03.130.294 Drill Guide Insert, yellow, for Drill Bits B 1.3 mm, for No. 03.130.291

03.130.293 Drill Guide Insert, red, for Drill Bits B 1.1 mm, for No. 03.130.291

03.130.295 Drill Guide Insert, red, for Drill Bits B 1.5 mm, for No. 03.130.291

03.130.296 Drill Guide Insert, blue, for Drill Bits B 1.5 mm, for No. 03.130.291

03.130.297 Drill Guide Insert, blue, for Drill Bits B 2.0 mm, for No. 03.130.291

03.130.280 Plate Holding Forceps with pointed ball tip

03.130.291 Reduction Forceps for Cortex Screws B 1.3 to 2.0 mm, soft lock, length 140 mm

03.130.140 Bending Pin for Locking Plates 1.3, with thread


TRIAL IMPLANTS

Trial Implants for Locking Plates 1.3 (Optional)

03.132.150 Trial Implant for Locking Plate 1.3, straight, 6 holes, length 24 mm

03.132.152 Trial Implant for Locking T-Plate 1.3, 3 holes head/5 holes shaft, length 26 mm

03.132.153 Trial Implant for Locking Y-Plate 1.3, 3 holes head/5 holes shaft, length 27 mm

03.132.154 Trial Implant for Locking Phalangeal Base Plate 1.3, 2 holes head/5 holes shaft, length 26 mm

03.132.156 Trial Implant for Locking Phalangeal Head Plate, 1.3, right, length 22 mm

03.132.157 Trial Implant for Locking Phalangeal Head Plate, 1.3, left, length 22 mm

03.132.158 Trial Implant for Locking Strut Plate 1.3, 8 holes, oblique-angled, right, length 19 mm

03.132.159 Trial Implant for Locking Strut Plate 1.3, 8 holes, oblique-angled, left, length 19 mm

03.132.161 Trial Implant for Locking Web Plate 1.3, 14 holes, length 29 mm


Trial Implants


03.132.250 Trial Implant for VA Locking Plate 1.5, straight, 6 holes, length 28 mm

03.132.252 Trial Implant for VA Locking T-Plate 1.5, 3 holes head/7 holes shaft, length 40 mm

03.132.253 Trial Implant for VA Locking Y-Plate 1.5, 3 holes head/7 holes shaft, length 42 mm

03.132.254 Trial Implant for VA Locking Phalangeal Base Plate 1.5, 2 holes head/6 holes shaft, length 36 mm

03.132.256 Trial Implant for VA Locking Phalangeal Head Plate, 1.5, right, length 26 mm

03.132.257 Trial Implant for VA Locking Phalangeal Head Plate, 1.5, left, length 26 mm

03.132.258 Trial Implant for VA Locking Strut Plate 1.5, 8 holes, oblique-angled, right, length 23 mm

03.132.259 Trial Implant for VA Locking Strut Plate 1.5, 8 holes, oblique-angled, left, length 23 mm

03.132.260 Trial Implant for VA Locking Strut Plate 1.5, 12 holes, rectangular, length 36 mm

03.132.261 Trial Implant for VA Locking Web Plate 1.5, 14 holes, length 33 mm



03.132.263 Trial Implant for VA Locking Plate 1.5, for Metacarpal I, dorsal, length 29 mm

03.132.264 Trial Implant for VA Locking Plate 1.5, for Metacarpal I, lateral, right

03.132.265 Trial Implant for VA Locking Plate 1.5, for Metacarpal I, lateral, left

03.132.267 Trial Implant for VA Locking Rotation Correction Fracture Plate 1.5, length 32 mm

03.132.268 Trial Implant for VA Locking Metacarpal Neck Fracture Plate 1.5, length 29 mm


Trial Implants


03.132.350 Trial Implant for VA Locking Plate 2.0, straight, 6 holes, length 35 mm

03.132.352 Trial Implant for VA Locking T-Plate 2.0, 3 holes head/7 holes shaft, length 50 mm

03.132.353 Trial Implant for VA Locking Y-Plate 2.0, 3 holes head/7 holes shaft, length 52 mm

03.132.354 Trial Implant for VA Locking Phalangeal Base Plate 2.0, 2 holes head/6 holes shaft, length 44 mm

03.132.360 Trial Implant for VA Locking Strut Plate 2.0, 12 holes, rectangular, length 45 mm

03.132.363 Trial Implant for VA Locking Plate 2.0, for Metacarpal I, dorsal, length 32 mm

03.132.367 Trial Implant for VA Locking Rotation Correction Fractures Plate 2.0, length 42 mm


CASE COMPONENTS AND MODULES

68.130.106 Locking Module 1.0/1.3 for VA Locking Hand System, without contents

68.130.110 Plate Module, for Locking Module 1.0/1.3 for VA Locking Hand System, without contents

68.130.113 Auxiliary Bin, for VA Locking Hand System Modules, without contents

68.130.206 VA Locking Module 1.5 for VA Locking Hand System, without contents

68.130.210 Plate Module Basic, for VA Locking Module 1.5 for VA Locking Hand System, without contents


Case Components and Modules

68.130.211 Plate Module Supplementary, for VA Locking Module 1.5 for VA Locking Hand System, without contents

68.130.306 VA Locking Module 2.0 for VA Locking Hand System, without contents

68.130.310 Plate Module Basic, for VA Locking Module 2.0 for VA Locking Hand System, without contents

68.130.311 Plate Module Supplementary, for VA Locking Module 2.0 for VA Locking Hand System, without contents

68.130.002 Standard Instruments Module for VA Locking Hand System, without contents


68.130.008 Additional Instruments Module for VA Locking Hand System, without contents

68.130.012 K-wire Rack 0.6, 0.8, 1.0, 1.25 mm, without contents

68.130.014 Storage Basket, for VA Locking Hand System, without contents

68.130.015 Storage Basket, for VA Locking Hand System, with Lid, without contents

Optional Set

01.900.020 Extraction Set for Standard Screws


ALSO AVAILABLE

398.410 Reduction Forceps, with Points, wide, ratchet lock, length 132 mm

398.950 Termite Forceps, ratchet lock, length 90 mm

399.970 Reduction Forceps with Points, ratchet lock, length 130 mm

319.390 Sharp Hook, length 155 mm

399.180 Bone Lever, small, short narrow tip, width 6 mm, length 160 mm

399.190 Bone Lever, small, short narrow tip, width 8 mm, length 160 mm

399.481 Periosteal Elevator, 3 mm width, curved blade, round edge


MRI INFORMATION

Torque, Displacement and Image Artifacts according to ASTM F 2213-06, ASTM F 2052-06e1 and ASTM F 2119-07Non-clinical testing of worst case scenario in a 3T MRI system did not reveal any relevant torque or displace-ment of the construct for an experimentally measured local spatial gradient of the magnetic field of 3.69T/m. The largest image artifact extended approximately 169 mm from the construct when scanned using the Gradient Echo (GE). Testing was conducted on a 3T MRI system.

Radio-Frequency-(RF-)induced heating according to ASTM F 2182-11aNon-clinical electromagnetic and thermal testing of worst case scenario lead to peak temperature rise of 9.5C with an average temperature rise of 6.6C (1.5T) and a peak temperature rise of 5.9C (3T) under MRI Conditions using RFCoils (whole body averaged specific absorption rate [SAR] of 2W/kg for 6 minutes [1.5T] and for 15minutes [3T]).

Precautions: The above mentioned test relies on non-clinical testing. The actual temperature rise in the patient will depend on a variety of factors beyond the SAR and time of RF application. Thus, it is recommended to pay particular attention to the following points: It is recommended to thoroughly monitor patients

undergoing MR scanning for perceived temperature and/or pain sensations.

Patients with impaired thermoregulation or temperature sensation should be excluded from MR scanning procedures.

Generally, it is recommended to use a MR system with low field strength in the presence of conductive implants. The employed specific absorption rate (SAR) should be reduced as far as possible.

Using the ventilation system may further contribute to reduce temperature increase in the body.

Synthes GmbHEimattstrasse 34436 OberdorfSwitzerlandTel: +41 61 965 61 11Fax: +41 61 965 66 00www.depuysynthes.com 0123

DeP

uy S

ynth

es T

raum

a, a

div

isio

n of

Syn

thes

Gm

bH. 2

016.

A

ll rig

hts

rese

rved

. D

SE

M/T

RM

/071

5/04

23(2

) 05

/16

Not all products are currently available in all markets.

This publication is not intended for distribution in the USA.

All surgical techniques are available as PDF files at www.depuysynthes.com/ifu

Documents

VARIABLE ANGLE LOCKING HAND SYSTEM - …synthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes International... · Variable Angle Locking Hand System Surgical Technique DePuy Synthes