The Titanium Cannulated Hindfoot Arthrodesis Nail TGsynthes.vo.llnwd.net/o16/LLNWMB8/US Mobile/Synthes North... · 2016-12-01 · The Titanium Cannulated Hindfoot Arthrodesis Nail

The Titanium Cannulated HindfootArthrodesis Nail. Expert Nailing System.

Technique Guide

Introduction

Surgical Technique

Product Information

Table of Contents

Titanium Cannulated Hindfoot Arthrodesis Nail 2Expert System

AO Principles 4

Indications 5

Preoperative Planning 6

Opening the Hindfoot 8

Reaming (recommended) 12

Inserting the Nail 13

Distal Locking with Spiral Blade 15

Distal Locking with 6.0 mm Locking Screws 19

Talar Locking 23

Proximal Locking 25

End Cap Insertion 27

Implant Removal (optional) 28

Implant Specifications 30

Implants 31

Instruments 36

Set Lists 42

Image intensifier control

Synthes

Advanced solutions

Improved stability

Distal and talar locking options Screw orientation options:

– Calcaneus toward the cuboid

– Talus toward the navicular

2 Synthes Titanium Cannulated Hindfoot Arthrodesis Nail Expert System Technique Guide

End caps– Securely lock spiral blade or the most distal locking screw

– Prevent ingrowth of soft tissue and facilitate nail extraction

– Sit flush with end of nail

– Self-retaining, T25 recess for easy pickup and insertion of end cap

– Titanium alloy*

* Ti-6Al-7Nb alloy

Titanium Cannulated Hindfoot Arthrodesis Nail Expert System

Spiral blade– Increased surface area optimizes load distribution

in the calcaneus

– Lengths: 45 mm–100 mm (5 mm increments)

– Cannulated for insertion over a 3.2 mm guide wire

– 12.5 mm blade diameter

– Front-cutting end

– Implants common with the Titanium Cannulated Retrograde/Antegrade Femoral Nail Expert System

– Titanium alloy*

For securing the spiral blade

For securing the most distallocking screw

5.0 mm

6.0 mm

Synthes 3

* Ti-6Al-7Nb alloy

Standard locking screws – Double-lead threads for ease of insertion

– Thread closer to screwhead for better bone purchase in the near cortex

– Self-tapping blunt tip

– Self-retaining, T25 StarDrive recess, improved torque transmission, increased resistance to stripping relativeto a hex recess, and secure locking screw pickup

– 6.0 mm for distal locking options

– 5.0 mm for talar and proximal locking options

– Titanium alloy*

Nail design– The lateral bend allows an entry site in the center of the

lateral column of the calcaneus

– Permits proper hindfoot alignment and restores 3°–5° valgus positioning for a better gait

– Cannulated for use over all Synthes 2.5 mm or 3.0 mm ball-tipped reaming rods. Reaming rods may be removed through the nail and the insertion handle assembly (no exchange tube required)

– Titanium alloy*

The nail design and aiming arm enable targeted medial-to-lateral or lateral-to-medial proximal locking.

AO Principles

In 1958, the AO formulated four basic principles, whichhave become the guidelines for internal fixation in general1, and intramedullary nailing in particular.

The Titanium Cannulated Hindfoot Arthrodesis Nail ExpertSystem enables an intramedullary approach for the fixationand the fusion of the ankle and of the subtalar joints. Fixationcan be extended across the medial column and calcaneo-cuboid joints. The system consists of a series of cannulatednails, cannulated spiral blades, cannulated end caps andlocking screws. All the implants are made of titanium alloy.

Anatomic reductionThe construct allows bone reduction and fixation to restoreanatomical relationships. The Hindfoot Arthrodesis Nail–EX is designed to anatomically align the ankle and hindfoot.

Stable fixationThe Hindfoot Arthrodesis Nail–EX provides secure fixation forankle and subtalar fusions. The use of the spiral blade withend cap or the distal locking screw with end cap provides afixed-angle construct ideal for patients with poor bone quality.

Preservation of blood supplyBlood supply to soft tissues and bone preserved by carefulhandling. The instruments and implants in the HindfootArthrodesis Nail–EX enable less soft tissue stripping thanother treatment methods.

Early, active mobilizationThe Hindfoot Arthrodesis Nail–EX provides secure fixation with minimal trauma to the vascular supply, which creates an improved environment for healing, and permits controlled,early, active rehabilitation conducive to optimum recovery.


1. M.E. Müller, M. Allgöwer, R. Schneider, and H. Willenegger. Manual of InternalFixation, 3rd Edition. Berlin: Springer-Verlag. 1991.

Indications

The Hindfoot Arthrodesis Nail–EX is indicated to facilitate tibiotalocalcaneal arthrodesis to treat:

– Severe foot /ankle deformity

– Arthritis

– Instability and skeletal defects after tumor resection; these include, but are not limited to neuro-osteoarthropathy(Charcot’s foot)

– Avascular necrosis of the talus

– Failed joint replacement or failed ankle fusion

– Distal tibial fracture nonunions

– Osteoarthritis

– Rheumatoid arthritis and pseudoarthrosis

Synthes 5

Preoperative Planning

1Estimate nail diameter and length

Use the AO preoperative planner template for the TitaniumCannulated Hindfoot Arthrodesis Nail–EX to estimate nail diameter and length.

To estimate nail diameter, place the template on the AP andlateral x-rays of the distal tibia and measure the diameter ofthe medullary canal at the narrowest part that will containthe nail.

To estimate nail length, place the template on the AP x-ray of the hindfoot and select the appropriate nail length basedon patient anatomy. When selecting nail size, consider canal diameter, indication, patient anatomy and postoperative protocol.

Note: Templates are available in two sizes: actual size and115% magnification in which image is enlarged 15% to correspond to typical radiographic magnification. However,variations in magnification levels are common.


2Position patient

Position the patient on a radiolucent operating table. Positionthe C-arm to allow visualization of the tibiotalar and subtalarjoints in both the AP and ML views.

Please note that the procedure can be done with the patientprone, or in lateral decubitus or supine positions according tosurgeon’s preference. However, the following techniquewith the patient in prone position is recommended.

Tip: Drape both limbs so that the contralateral limb can provide a biological reference for controlling angulation.

3Determine nail length and diameter

Instrument

03.008.001 Radiographic Ruler

Measure length Position the C-arm for a lateral view of the distal tibia andsubtalar joint. With long forceps, hold the radiographic rulerparallel to the tibia.

Adjust the ruler until the distal end is at the desired nail insertion depth. Mark the skin at that site on the lateral side.

Move the image intensifier proximally with the ruler positionedon the distal skin mark. An image of the ruler can be used tochoose the optimum nail length.

Measure diameterPosition the C-arm for a lateral view of the tibia with the distal tibia centered on the screen.

Hold the ruler over the tibia so that the diameter gauge is centered over the narrowest part of the medullary canalthat will contain the nail.

Read the diameter measurement on the circular indicator to estimate the canal size.

Synthes 7

Opening the Hindfoot

1Perform fibula osteotomy

Create an incision laterally over the fibula. Curve the approachanteriorly, just distal to the tip of the fibula. Dissection to thebone is directed anteriorly. Using a sagittal saw, create an osteotomy 10 cm from the distal tip of the fibula. Resect approximately 1 cm of bone proximal to the first cut, creatinga gap. This bone segment can be utilized as bone graft.

Incise the anterior soft tissue including anterior tibiofibular,calcaneofibular and talofibular ligaments.

Take care to preserve the posterior soft tissue. By maintaininga blood supply to this bone, it can be used later as a biolog-ical plate on the lateral distal tibia.

Reflect the distal segment posteriorly hinging on the posteriorligaments.

Using a sagittal saw, remove the medial fibular cortex and articular surface. Maintain the bone to be utilized asbone graft.

2Prepare articular surfaces for fusion

Prepare the articular surfaces of the ankle and subtalar jointsfor fusion.

Prepare the incisure and lateral talus for arthrodesis with thefibula later in the procedure.

Technique tips:Drill multiple holes in the subchondral bone to encouragethe fusion.

Be sure to adequately prepare the subtalar articular surface,as this is a common site of failure for fusion.


3Determine entry point

Instrument

03.010.115 3.2 mm Guide Wire, 290 mm

On a lateral fluoroscopic image, identify and mark the centerof the tibial canal with the help of the 3.2 mm guide wireheld adjacent to the leg.

Identify the center of the calcaneus along its plantar surface.The intersection of the lateral reference line and the longitu-dinal axis of the calcaneus approximates the entry point.Make a longitudinal incision over the plantar aspect of thebody of the calcaneus.

Note: The plantar aponeurosis is incised parallel to the skin incision and slightly lateral of center. This prevents theaponeurosis from influencing the entry point.

4Insert guide wire though calcaneus and talus

Instruments

03.010.115 3.2 mm Guide Wire, 290 mm

357.127 13.0 mm Protection Sleeve

357.128 13.0 mm/3.2 mm Trocar

Thread the 13.0 mm/3.2 mm trocar into the 13.0 mm protection sleeve. Insert this assembly through the incisionto the bone. Hold the protection sleeve firmly and insert the3.2 mm guide wire through the trocar. Under power, insertthe guide wire through the center of the lateral column of the calcaneus, angling medially toward the center of the talar dome.

Direct the guide wire so it exits the talus in the center of the articular surface in both AP and ML views.

Synthes 9

5Open canal

Instruments

03.008.008 5.0 mm Three-Fluted Drill Bit, quick coupling

351.27 13.0 mm Cannulated Drill Bit, 300 mm


Remove the trocar from the protection sleeve. Place the13.0 mm cannulated drill bit over the guide wire and throughthe protection sleeve to the bone. Drill through the calcaneusand talus until the opening drill exits the talus. Take care toavoid the tibial plafond.

Remove the 3.2 mm guide wire.


Opening the Hindfoot continued

Invert the hindfoot and insert the 5.0 mm drill bit throughthe canal created in the calcaneus and talus. Under imaging,center the drill point under the tibial canal in both the APand lateral planes. Use the drill to create a defect in the subchondral bone to allow passage of the ball tip reaming rod.

Synthes 11

Reaming (recommended)

6Reaming (recommended)

Instruments

03.010.024 Holding Device, for Guide Wires and Reaming Rods

351.706S 2.5 mm Reaming Rod with ball tip, 950 mm, sterile

351.707S 2.5 mm Reaming Rod with ball tip and extension, 950 mm, sterile

Recommended set

150.060 Flexible Reamer Set for IM Nails

Insert reaming rodInsert the reaming rod through the calcaneus and talus into the medullary canal of the tibia.

ReamStarting with the 8.5 mm reaming head, ream in 0.5 mm increments to a diameter of 1 mm larger than the nail diameter. Advance the reamer with steady, moderate pressure and do not force it. Partially retract the reamer often to clear debris from the medullary canal.

Note: All nails in the hindfoot arthrodesis nail expert systemcan be inserted over the 2.5 mm and 3.0 mm reaming rodswith ball tip. Reaming rod exchange is not required.

Optional technique

Instrument

03.010.093 Reaming Rod Push Rod

Use the reaming rod push rod to help retain the reaming rodduring reamer extraction.


Inserting the Nail

1Assemble insertion instruments

Instruments

03.008.007 Insertion Handle

03.010.092 Ball Hex Screwdriver, 8 mm

03.010.146 Cannulated Connecting Screw, with InternalThread, for Percutaneous Insertion Handle

Orient the nail so that it matches the nail diagram on the insertion handle.

Match the tang on the handle to the notch in the HindfootArthrodesis Nail–EX. Place the connecting screw into the insertion handle and thread it into the nail, using the 8 mmball hex screwdriver.

The aligned tangs will interface properly only if the nail bendis oriented toward the flat portion of the insertion handle.

Synthes 13

Inserting the Nail continued

2Insert nail

Instruments

03.008.005 Driving Cap


03.010.056 Slide/Fixed Hammer, 700 grams

321.17 4.5 mm Pin Wrench, 120 mm

Verify reduction and alignment under image intensification.

Note: While inserting the nail, the flat portion of the insertionhandle should be facing laterally.

Using a twisting motion, insert the nail over the reaming rodas far as possible. Use the insertion assembly to manipulatethe nail across the joints. Insert the nail until its instrumentend is flush with the calcaneal opening.

If needed, use light, controlled hammer blows to seat thenail. Thread the driving cap onto the insertion handle. Lock the head of the slide/fixed hammer in place, using the 4.5 mm pin wrench to tighten the nut onto the threadsbelow the hammer head. Strike the driving cap directly.

Confirm that the nail has aligned the foot anatomically.

Once the nail is seated, remove the driving cap.

Note: The nail depth should be determined by optimal positionof the most critical locking option, i.e. spiral blade position ortalar screw.

Optional technique

Instrument

357.22 Hammer Guide

The hammer guide can be threaded into the driving cap andthe hammer can be used as a slide hammer. Loosen the nutfrom the threads below the hammer head and secure it ontothe threads located above the handle.


Distal Locking with Spiral Blade

Notes: Distal locking first is recommended, to allow later compressionacross joints being fused.

Distal locking options include a spiral blade with or without a 6.0 mm locking screw, or two 6.0 mm locking screws.

Optimal talar screw placement will dictate nail depth and rotation. If this is determined to be a critical screw, the distallocking procedure may be started with this screw. However,this method limits positioning of calcaneus locking elements.

Technique tip: Screw orientation can be estimated by placinga 3.2 mm guide wire through the appropriate holes of theinsertion handle. With the foot in weight-bearing position,the guide wire should be aligned with the medial columnthrough the talar hole, or the fourth ray when placed throughthe posterior to anterior hole.

Synthes 15

Protection sleeve

Threaded alignmentpin

Insertionhandle

Aiming arm

1Confirm nail and spiral blade position

Instruments

03.008.004 Threaded Alignment Pin

03.008.009 Aiming Arm

03.010.081 15.0 mm/13.0 mm Protection Sleeve

03.010.082 13.0 mm/3.2 mm Wire Guide, for spiralblade aiming arm

03.010.115 3.2 mm Guide Wire, 290 mm

Partially thread the alignment pin into the aiming arm.

Attach the aiming arm to the insertion handle. Orient theaiming arm so the letter “P”, for posterior, can been seen on the insertion handle. Tighten the threaded alignment pin.

Distal Locking with Spiral Blade continued


1Confirm nail and spiral blade position continued

Assemble the protection sleeve and wire guide and insert the sleeve assembly into the aiming arm. Create a posterior incision and advance the sleeve to the bone.

Insert a guide wire through the wire guide into the calcaneusuntil the tip is flush with the anterior cortex. Confirm wireposition radiographically. This position will determine the final position of the spiral blade.

2Measure for spiral blade length

Instrument

03.010.083 Spiral Blade Measuring Device

Remove the wire guide. Place the spiral blade measuring device over the guide wire and advance it to the bone. Readthe graduation of the measuring device at the end of theguide wire. This measurement is the length of the spiral blade.

3Open posterior cortex

Instrument


Make an incision to split the Achilles tendon before insertingthe spiral blade, to prevent damage to the soft tissue andrisk of necrosis.

Insert the cannulated drill bit over the guide wire and throughthe protection sleeve to perforate the posterior cortex. Anautomatic stop prevents the drill bit from penetrating too far.Remove the drill bit and protection sleeve, leaving the guidewire in place.

4Attach adapter

Instrument

03.008.010 Aiming Arm Adapter

Attach the aiming arm adapter.

Synthes 17

Distal Locking with Spiral Blade continued


5Insert spiral blade

Instruments

03.008.011 Spiral Blade Inserter


357.34 Connecting Screw, for Titanium Spiral Blades

Attach the appropriate length spiral blade to the spiral bladeinserter using the connecting screw.

Pass the spiral blade assembly over the guide wire. Advancethe spiral blade inserter through the aiming arm adapter, ensuring engagement of the inserter’s helical grooves withthe mating pins of the aiming arm adapter.

Manually advance the spiral blade to the bone. Use light,controlled blows of the slide/fixed hammer in a fixed positionto seat the spiral blade. Advancement should be monitoredradiographically.

The correct insertion depth is reached when the spiral bladehead is flush with the posterior cortex.

Remove the spiral blade connecting screw and spiral bladeinserter and adapter.

Remove the 3.2 mm guide wire.

6Insert second distal locking screw (optional)

Follow the standard locking procedure with the 12.0 mm/8.0 mm protection sleeve, if insertion of a second distal locking element is desired.

Distal Locking with 6.0 mm Locking Screws

Synthes 19

1Confirm nail and screw position

Instruments

03.008.002 18.0 mm/8.0 mm Protection Sleeve, 188 mm



03.010.064 8.0 mm/3.2 mm Drill Sleeve, 200 mm

03.010.069 3.2 mm Trocar

357.399 3.2 mm Guide Wire, 400 mm

Insert the alignment pin into the aiming armAttach the aiming arm to the insertion handle. Orient theaiming arm so the letter “P”, for posterior, can been seen on the insertion handle. Tighten the threaded alignment pin.

Insert trocar combinationInsert the three-part trocar combination (protection sleeve,corresponding drill sleeve and trocar) through the most inferiorhole of the aiming arm. Make a vertical incision sufficient toretract and protect the skin edges to avoid compromising thewound. Insert the trocar to the bone. Remove the trocar.

Verify nail insertion depth and location by inserting a 3.2 mmguide wire through the drill sleeve into the bone. Confirmguide wire position radiographically. This position will determinethe final position of the most distal locking screw.

Protection sleeve

Threaded alignmentpin

Insertionhandle

Aiming arm

3Drill and determine locking screw length

Instruments


03.008.008 5.0 mm Three-Fluted Drill Bit, quick coupling,356 mm, 126 mm calibration


03.010.071 5.0 mm Trocar, 210 mm

Remove the initial 3.2 mm guide wire to allow screwpredrilling. Insert the 8.0 mm/5.0 mm drill sleeve into the protection sleeve.

Advance the 5.0 mm drill bit to the subchondral bone ofthe anterior process of the calcaneus.

Confirm drill bit position radiographically.


Distal Locking with 6.0 mm Locking Screws continued

2Maintain aiming arm in position

Instrument

03.010.115 3.2 mm Guide Wire, 290 mm

Insert a second 3.2 mm guide wire under power through the hole in the aiming arm. This will maintain aiming arm position through the initial locking screw insertion.

Synthes 21

Ensure that the drill sleeve is pressed firmly to the bone and read the locking screw length directly from the drill bit, at the back of the drill sleeve.

Remove the drill bit and drill sleeve.

Alternative instrument

03.010.072 Depth Gauge

Disassemble the depth gauge into two parts: the outer sleeveand the measuring device with hook. Insert the measuringdevice into the protection sleeve.

Advance the measuring device to the desired depth, andconfirm with imaging. Make sure that the protection sleeveis flush to the bone.

Read the measurement from the back of the protectionsleeve, which indicates the appropriate length locking screw.

4Insert most distal locking screw

Instruments


03.010.108 StarDrive Screwdriver, T25, self-retaining

Insert the appropriate length 6.0 mm locking screw throughthe protection sleeve using the StarDrive screwdriver.

Verify locking screw length under image intensification.

Remove the 3.2 mm aiming arm stabilization wire.


5Insert second distal locking screw

Instrument


Repeat the procedure for a second distal locking screw, using the 12.0 mm/8.0 mm protection sleeve.

Distal Locking with 6.0 mm Locking Screws continued

Talar Locking

1Drill and determine length of talar locking screw

Instruments




03.010.056 Slide Fixed Hammer, 700 grams

03.010.061 4.2 mm Three-Fluted Drill Bit, quick coupling,330 mm, 100 mm calibration



03.010.070 4.2 mm Trocar, 210 mm

If compression across the subtalar joint is desired, remove the aiming arm by loosening the threaded alignment pin.Thread the driving cap to the insertion handle and use lighthammer blows until the gap is sufficiently reduced.

Reattach the aiming arm.

Loosen the threaded alignment pin and rotate the aimingarm laterally so the letter “T”, for talus, can be seen on theinsertion handle.

Retighten the threaded alignment pin.

Insert the three-part trocar combination (protection sleeve,drill sleeve and trocar) into the aiming arm and through a stab incision to the bone. Remove the trocar.

Drill to the anterior side of the talus, using the 4.2 mm drillbit. Confirm drill bit position radiographically.

Ensure that the drill sleeve is pressed firmly to the bone andread the locking screw length directly from the drill bit at the back of the drill sleeve.

Remove the drill bit.

Synthes 23


Talar Locking continued

1Drill and determine length of talar locking screw continued



After drilling through the talus, remove the drill bit and the drill sleeve.

Disassemble the depth gauge into two parts: the outersleeve and the measuring device with hook. Insert the measuring device into the protection sleeve. Ensure that thehook grasps the far cortex and the protection sleeve is flushto the bone. Read the measurement from the back of theprotection sleeve, which indicates the appropriate lengthlocking screw.

2Insert talar screw

Instruments



Insert the appropriate locking screw through the protectionsleeve using the StarDrive screwdriver.

Verify locking screw length under image intensification.

Note: If starting with a talar screw, please refer to page 19for calcaneus locking screws, or page 15 for spiral blade positioning.

Proximal Locking

1Drill and determine length of proximal screw

Instruments





03.010.056 Slide Fixed Hammer, 700 grams

03.010.061 4.2 mm Three-Fluted Drill Bit, quick coupling, 330 mm, 100 mm calibration



03.010.070 4.2 mm Trocar, 210 mm

If compression across the ankle joint is desired, remove the aiming arm by loosening the threaded alignment pin.Thread the driving cap into the insertion handle and use lighthammer blows until the gap is sufficiently reduced. Reattachthe aiming arm and orient it so the letter “M” for medial or“L” for lateral can be seen on the insertion handle.

Tighten the threaded alignment pin.

Choose the screw position (in the static hole or in the dynamicslot). The dynamic slot allows controlled dynamization of thebone fragments.

Insert the protection sleeve, drill sleeve and trocar assemblyinto the aiming arm and through a stab incision to the bone.

Remove the trocar.

Drill through both cortices using the calibrated drill bit, stopping the drill immediately after penetrating the far cortex. Confirm drill bit position radiographically.

Synthes 25


1Drill and determine length of proximal screw continued

Ensure that the drill sleeve is pressed firmly to the bone andread the locking screw length directly from the drill bit at theback of the drill sleeve.

Remove the drill bit and drill sleeve.



Measure screw length as described above, using the depth gauge.

2Insert proximal screws

Instruments



Insert the appropriate length locking screw through the protection sleeve, using the StarDrive screwdriver. Verify locking screw length under image intensification.

Repeat the procedure for a second proximal locking screw, if desired.

Proximal Locking continued

End Cap Insertion

1Insert end cap

Instrument


Remove the nail insertion instruments.

For locking screws, insert the aqua end cap with theStarDrive screwdriver.

For a spiral blade, insert the gold end cap with the StarDrivescrewdriver.

Turn the end cap clockwise to thread it into the nail until it engages the distal screw or spiral blade.

Technique tip: To minimize the chance of cross-threading,turn the end cap counterclockwise until the threads of theend cap align with the threads of the nail.

Note: Fix the fibula as a live biological plate, using two 3.5 mm titanium cortex screws.

Synthes 27


Implant Removal (optional)

1Remove end cap

Instrument


Clear the StarDrive recesses of the end cap and the locking implants of any tissue ingrowth. Remove the end cap, usingthe StarDrive screwdriver.

2Remove spiral blade

Instruments



357.22 Hammer Guide, for Slide Hammer

357.36 Extraction Screw

Thread the spiral blade extraction screw into the hub of the spiral blade.

Thread the hammer guide into the extraction screw. Use controlled blows of the slide/fixed hammer to extract the spiral blade.

Leave a loose grip on the extraction assembly, as it and the blade rotate during extraction.

3Remove locking screws

Instruments



Remove all but the most proximal locking screw.

Attach the extraction screw to the nail.

4Remove nail

Instruments





Attach the hammer guide to the extraction screw.

Remove the last locking screw.

Remove the nail by applying gentle blows with the hammer.

Synthes 29


Implant Specifications

Titanium Hindfoot Arthrodesis Cannulated Nail–EX – Right and left designs

– Cannulated for use over all Synthes 2.5 mm/3.0 mm ball-tipped reaming rods

Material– Titanium-6% aluminum-7%

niobium alloy

Diameters– 10 mm, 12 mm and 13 mm

– 10 mm and 12 mm nails have a 12.5 mm distal diameter

– 13 mm nails have a 13 mm distal diameter

Color– Light green

Lengths– 150 mm, 180 mm and

240 mm

Cross section– 10 mm nails are round

– 12 mm and 13 mm nails are fluted

– 240 mm length nails have a 9 mm proximal diameter

Proximal locking– Fully targeted from lateral

or medial side

– Dynamization slot (5.0 mm locking screw)

– Static transverse locking hole (5.0 mm locking screw)

Distal locking– Static oblique locking

(5.0 mm locking screw)

– Static transverse locking (6.0 mm locking screw)

– Spiral blade slot (spiral blade or 6.0 mm locking screw)

11.5 mm

22.5 mm

40 mm

100 mm

126.5 mm133.5 mm

160 mm

9 mm dia.

Implants

Synthes 31

Titanium Hindfoot Arthrodesis Cannulated Nail–EX,sterile

10 mm diameterLength (mm) right left150 04.008.010S 04.008.060S180 04.008.016S 04.008.066S240 04.008.028S 04.008.078S



Implants continued


5.0 mm Titanium Locking Screws◊, with T25 StarDriverecess, for IM Nails (light green)

– Titanium alloy*

– Lengths: 26 mm–80 mm (2 mm increments)85 mm–100 mm (5 mm increments)

– 4.3 mm core diameter

– Fully threaded

– Self-tapping, blunt tip

Length (mm) Length (mm)04.005.516 26 04.005.548 58 04.005.518 28 04.005.550 60 04.005.520 30 04.005.552 62 04.005.522 32 04.005.554 64 04.005.524 34 04.005.556 66 04.005.526 36 04.005.558 68 04.005.528 38 04.005.560 70 04.005.530 40 04.005.562 72 04.005.532 42 04.005.564 74 04.005.534 44 04.005.566 76 04.005.536 46 04.005.568 7804.005.538 48 04.005.570 8004.005.540 50 04.005.575 85 04.005.542 52 04.005.580 90 04.005.544 54 04.005.585 95 04.005.546 56 04.005.590 100

◊ Available nonsterile or sterile-packed. Add “S” to catalog number to order sterile product.

* Ti-6Al-7Nb alloy

Synthes 33


* Ti-6Al-7Nb alloy† Also available

6.0 mm Titanium Locking Screws◊, with T25 StarDriverecess, for IM Nails (aqua)

– Titanium alloy*

– Lengths: 26 mm–60 mm (2 mm increments)64 mm–80 mm (4 mm increments)85 mm–125 mm (5 mm increments)

– 4.8 mm core diameter

– Fully threaded

– Self-tapping, blunt tip

Length (mm) Length (mm)04.005.616† 26 04.005.648 58 04.005.618† 28 04.005.650 60 04.005.620† 30 04.005.654 64 04.005.622† 32 04.005.658 68 04.005.624† 34 04.005.662 72 04.005.626† 36 04.005.666 76 04.005.628† 38 04.005.670 80 04.005.630† 40 04.005.675 85 04.005.632† 42 04.005.680 90 04.005.634† 44 04.005.685 9504.005.636† 46 04.005.690 10004.005.638 48 04.005.691 105 04.005.640 50 04.005.692 110 04.005.642 52 04.005.693 115 04.005.644 54 04.005.694 120 04.005.646 56 04.005.695 125

Implants continued



* Ti-6Al-7Nb alloy

Titanium Spiral Blades◊ (gold)

– Titanium alloy*

– Lengths: 45 mm–100 mm (5 mm increments)

– Cannulated for insertion over a 3.2 mm guide wire

– 12.5 mm blade diameter

– Front-cutting end

Length (mm)

04.013.041 45 04.013.042 50 04.013.043 55 04.013.044 60 04.013.045 65 04.013.046 70 04.013.047 75 04.013.048 80 04.013.049 8504.013.050 9004.013.051 9504.013.052 100

Titanium End Cap◊, with T25 StarDrive recess, forHindfoot Arthrodesis Nail–EX Spiral Blade (gold)

– Titanium alloy*

– Mandatory to securely lock the spiral blade

– Sits flush with end of nail (no extension)

– Protects nail threads from tissue ingrowth

04.008.000 End Cap, for securing the spiral blade

Titanium End Cap◊, with T25 StarDrive recess, for Hindfoot Arthrodesis Nail–EX (aqua)

– Titanium alloy*

– Securely locks the most distal locking screw

– Sits flush with end of nail (no extension)

– Protects nail threads from tissue ingrowth

04.008.001 End Cap, for securing the most distal locking screw

Synthes 35


* Ti-6Al-7Nb alloy


Instruments

03.008.001 Radiographic Ruler, for Titanium Cannulated Hindfoot Arthrodesis Nail–EX


03.008.009 Aiming Arm for Titanium Cannulated Hindfoot Arthrodesis Nail–EX





Synthes 37




03.008.011 Spiral Blade Inserter for Hindfoot ArthrodesisNail–EX

03.008.010 Aiming Arm Adapter for Titanium CannulatedHindfoot Arthrodesis Nail–EX

Instruments continued






03.010.069 3.2 mm Trocar

03.010.070 4.2 mm Trocar, 210 mm

03.010.071 5.0 mm Trocar, 210 mm

03.010.072 Depth Gauge, for Locking Screws to 100 mmfor IM Nails

Synthes 39

03.010.083 Spiral Blade Measuring Device, for Retrograde Femoral Nail–EX

03.010.092 Ball Hex Screwdriver, 8 mm

03.010.093 Reaming Rod Push Rod, with Ball Handle

03.010.108 StarDrive Screwdriver, T25, self-retaining, long

03.010.109 StarDrive Screwdriver Shaft, T25, self-retaining,quick coupling, 280 mm

03.010.082 13.0 mm/3.2 mm Wire Guide, for Spiral Blade Aiming Arm

03.010.081 15.0 mm/13.0 mm Protection Sleeve, for Spiral Blade Aiming Arm



03.010.112 Holding Sleeve, with Locking Device

03.010.146 Cannulated Connecting Screw, with InternalThread, for Percutaneous Insertion Handle


03.010.115 3.2 mm Guide Wire, 290 mm

321.20 Ratchet Wrench, 11 mm width across flats



357.34 Connecting Screw, for Titanium Spiral Blades, for use with Spiral Blade Inserter


357.398 Cannulated Shaft with 8 mm hex, 125 mm

357.399 3.2 mm Guide Wire, 400 mm

Synthes 41


357.128 13.0 mm /3.2 mm Trocar


Hindfoot Arthrodesis Nail–EX Instrument Set (01.008.003)

Graphic Case690.540 Graphic Case for Titanium Hindfoot Arthrodesis

Nail–EX

Instruments03.008.001 Radiographic Ruler, for Titanium Cannulated

Hindfoot Arthrodesis Nail–EX


03.008.004 Threaded Alignment Pin, 2 ea.

03.008.005 Driving Cap, for Hindfoot Arthrodesis Nail–EX

03.008.007 Insertion Handle, for Hindfoot ArthrodesisNail–EX

03.008.008◊ 5.0 mm Three-Fluted Drill Bit, quick coupling,356 mm, 126 mm calibration, 2 ea.

03.008.009 Aiming Arm, for Titanium CannulatedHindfoot Arthrodesis Nail–EX

03.008.010 Aiming Arm Adapter for Titanium Cannulated Hindfoot Arthrodesis Nail–EX

03.008.011 Spiral Blade Inserter for Hindfoot ArthrodesisNail–EX



03.010.061◊ 4.2 mm Three-Fluted Drill Bit, quick coupling,330 mm, 100 mm calibration, 2 ea.





03.010.069 3.2 mm Trocar

03.010.070 4.2 mm Trocar, 210 mm

03.010.071 5.0 mm Trocar, 210 mm


Note: For additional information, please refer to package insert. For detailed cleaning and sterilization instructions, please refer tohttp://us.synthes.com/Medical+Community/Cleaning+and+Sterilization.htmor to the below listed inserts, which will be included in the shipping container:– Processing Synthes Reusable Medical Devices—Instruments, Instrument Trays

and Graphic Cases—DJ1305– Processing Non-sterile Synthes Implants—DJ1304

Synthes 43


03.010.072 Depth Gauge, for Locking Screws to 100 mmfor IM Nails

03.010.0811 5.0 mm/13.0 mm Protection Sleeve, for Spiral Blade Aiming Arm

03.010.082 13.0 mm/3.2 mm Wire Guide, for SpiralBlade Aiming Arm

03.010.083 Spiral Blade Measuring Device, forRetrograde Femoral Nail–EX

03.010.092 Ball Hex Screwdriver, 8 mm03.010.093 Reaming Rod Push Rod, with Ball Handle03.010.108 StarDrive Screwdriver, T25, self-retaining,

long03.010.109 StarDrive Screwdriver Shaft, T25, self-

retaining, quick coupling, 280 mm03.010.112 Holding Sleeve, with Locking Device03.010.115 3.2 mm Guide Wire, 290 mm, 5 ea.03.010.146 Cannulated Connecting Screw, with Internal

Thread, for Percutaneous Insertion Handle, 2 ea.

321.17 4.5 mm Pin Wrench, 120 mm321.20 Ratchet Wrench, 11 mm width across flats351.27◊ 13.0 mm Cannulated Drill Bit, 300 mm357.127 13.0 mm Protection Sleeve357.128 13.0 mm/3.2 mm Trocar357.22 Hammer Guide, for Slide Hammer357.34 Connecting Screw, for Titanium Spiral Blades,

for use with Spiral Blade Inserter357.36 Extraction Screw357.398 Cannulated Shaft with 8 mm hex, 125 mm357.399 3.2 mm Guide Wire, 400 mm, 5 ea.



Hindfoot Arthrodesis Nail–EX Implant Set (01.008.004)

Graphic Case690.502 Screw/Blade Rack for Femoral Nail–EX

Implants

Implants5.0 mm Titanium Locking Screws◊, with T25 StarDrive recess,for IM Nails, 2 ea.

Length (mm)

04.005.516 26 04.005.518 28 04.005.520 30 04.005.522 32 04.005.524 34 04.005.526 36 04.005.528 38 04.005.530 40 04.005.532 42 04.005.534 44 04.005.536 46 04.005.538 48 04.005.540 50 04.005.542 52 04.005.544 54 04.005.546 56

Length (mm)04.005.548 58 04.005.550 60 04.005.552 62 04.005.554 64 04.005.556 66 04.005.558 68 04.005.560 70 04.005.562 72 04.005.564 74 04.005.566 76 04.005.568 78 04.005.570 80 04.005.575 85 04.005.580 90 04.005.585 95 04.005.590 100


6.0 mm Titanium Locking Screws◊, with T25 StarDrive recess,for IM Nails, 2 ea.

Length (mm)

04.005.638 48 04.005.640 50 04.005.642 52 04.005.644 54 04.005.646 56 04.005.648 58 04.005.650 60 04.005.654 64 04.005.658 68 04.005.662 7204.005.666 76

Length (mm)

04.005.670 80 04.005.675 85 04.005.680 90 04.005.685 95 04.005.690 10004.005.691 105 04.005.692 11004.005.693 11504.005.694 12004.005.695 125

Titanium Spiral Blades◊ (gold)Length (mm)

04.013.041 4504.013.042 5004.013.043 5504.013.044 6004.013.045 6504.013.046 70

Titanium End Caps◊, with T25 StarDrive recess, for HindfootArthrodesis Nail– EX, 2 ea.04.008.000 0 mm extension, for securing the spiral blade

(gold)04.008.001 0 mm extension, for securing the most distal

locking screw (aqua)

Length (mm)

04.013.047 7504.013.048 8004.013.049 8504.013.050 9004.013.051 9504.013.052 100

Synthes

Also Available

Set145.434 Small Fragment LCP Instrument and Titanium

Implant Set, with self-tapping screws

150.060 Flexible Reamer Set for IM Nails

Instruments03.010.151 Star /HexDrive Screwdriver Shaft, T25,

3.5 mm hex, self-retaining, 165 mm

03.010.152 Star /HexDrive Screwdriver Shaft, T25, 3.5 mm hex, self-retaining, 280 mm

351.706S 2.5 mm Reaming Rod with ball tip, 950 mm length, sterile

351.707S 2.5 mm Reaming Rod with ball tip andextension, 950 mm length, sterile

351.71◊ 3.0 mm Reaming Rod, with offset ball tip,950 mm length

351.76◊ 3.0 mm Reaming Rod, with straight ball tip,950 mm length

357.408 Cleaning Stylet, 3.2 mm

357.409 Cleaning Brush, 3.2 mm

Power Equipment511.30 Radiolucent Drive

511.73 Jacobs Chuck with Key (large)

511.75 Quick Coupling for Drill Bits

511.761 Large Quick Coupling

511.785 Reduction Drive Unit

511.791 Quick Coupling for Kirschner wires

530.100 Power Drive

530.200 Battery, for Power Drive

530.280 Battery Casing, for Power Drive


Implants6.0 mm Titanium Locking Screws◊, with T25 StarDrive recess,for IM Nails

Length (mm) Length (mm)

04.005.616 26 04.005.628 3804.005.618 28 04.005.630 40 04.005.620 30 04.005.632 42 04.005.622 32 04.005.634 44 04.005.624 34 04.005.636 46 04.005.626 36

Synthes (USA)1302 Wrights Lane EastWest Chester, PA 19380Telephone: (610) 719-5000To order: (800) 523-0322Fax: (610) 251-9056

Synthes (Canada) Ltd.2566 Meadowpine BoulevardMississauga, Ontario L5N 6P9Telephone: (905) 567-0440To order: (800) 668-1119Fax: (905) 567-3185

© 2007 Synthes, Inc. or its affiliates. All rights reserved. LCP and Synthes are trademarks of Synthes, Inc. or its affiliates. Printed in U.S.A. 4/10 J7028-D

www.synthes.com

Documents

The Titanium Cannulated Hindfoot Arthrodesis Nail TGsynthes.vo.llnwd.net/o16/LLNWMB8/US Mobile/Synthes North... · 2016-12-01 · The Titanium Cannulated Hindfoot Arthrodesis Nail