Expert Nailing System Titanium Cannulated Hindfoot ...synthes.vo.llnwd.net/o16/LLNWMB8/US Mobile/Synthes North America... · 4 DePuy Synthes Titanium Cannulated Hindfoot Arthrodesis

Expert Nailing System

Titanium Cannulated Hindfoot Arthrodesis NailSurgical Technique

Introduction

Surgical Technique

Product Information

Image intensifier control

Table of Contents

Titanium Cannulated Hindfoot Arthrodesis Nail Surgical Technique DePuy Synthes 1

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

MR Information The Titanium Cannulated Hindfoot Arthrodesis Nail System has not been evaluated for safety and compatibility in the MR environment. It has not been tested for heating, migration, or image artifact in the MR environment. The safety of the Titanium Cannulated Hindfoot Arthrodesis Nail System in the MR environment is unknown. Scanning a patient who has this device may result in patient injury.

2 DePuy Synthes Titanium Cannulated Hindfoot Arthrodesis Nail Surgical Technique

*Ti-6Al-7Nb alloy

Titanium Cannulated Hindfoot Arthrodesis Nail Expert System

Advanced SolutionsDistal and talar locking optionsScrew orientation options:• Calcaneus toward the cuboid• Talus toward the navicular

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 Expert Nailing System• Titanium alloy*


*Ti-6Al-7Nb alloy

For securingthe spiral blade

For securingthe most distallocking screw

5.0 mm

6.0 mm

Improved StabilityEnd 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*

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 DePuy 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 targetedmedial-to-lateral or lateral-to-medial proximal locking.

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 StarDriveTM Recess, improved torque

transmission, increased resistance to stripping relative to 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*

Titanium Cannulated Hindfoot Arthrodesis Nail Expert System


AO Principles

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

2 Rüedi 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.

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

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. Müller ME, Allgöwer M, Schneider R, Willenegger H. Manual of Internal Fixation. 3rd ed. Berlin, Heidelberg, New York: Springer-Verlag; 1991.

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


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

ContraindicationsThe Expert Hindfoot Arthrodesis Nail system is not recommended for:• Dysvascular limp• Active infection• Insufficient plantar pad


Preoperative Planning

1. Estimate nail diameter and lengthUse the AO preoperative planner template for the Titanium Cannulated Hindfoot Arthrodesis Nail–EX to estimate nail diameter and length.

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

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

Note: Templates are available in two sizes: actual size and 115% magnification in which image is enlarged 15% to correspond to typical radiographic magnification.

2. Position patientPosition the patient on a radiolucent operating table. Position the C-arm to allow visualization of the tibiotalar and subtalar joints in both the AP and ML views.

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

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


Preoperative Planning

3. Determine nail length and diameter

Instrument

03.008.001 Radiographic Rule

Measure lengthPosition the C-arm for a lateral view of the distal tibia andsubtalar joint. With long forceps, hold the radiographic ruler parallel to the tibia.

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

Move the image intensifier proximally with the ruler positioned on the distal skin mark. An image of the ruler can be used to choose the optimum nail length.

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

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

Read the diameter measurement on the circular indicatorto estimate the canal size.


Opening the Hindfoot

1. Perform fibula osteotomyCreate an incision laterally over the fibula. Curve the approach anteriorly, just distal to the tip of the fibula. Dissection to the bone 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, creating a 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 maintaining a blood supply to this bone, it can be used later as a biological plate on the lateral distal tibia.

Reflect the distal segment posteriorly hinging on the posterior ligaments.

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

2. Prepare articular surfaces for fusionPrepare the articular surfaces of the ankle and subtalar jointsfor fusion.

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

Notes:• Drill multiple holes in the subchondral bone to

encourage the fusion• Be sure to adequately prepare the subtalar articular

surface, as this is a common site of failure for fusion



3. Determine entry point

Instrument

03.010.115 3.2 mm Guide Wire, 290 mm

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

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

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

4. Insert 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 mmprotection sleeve. Insert this assembly through the incisionto the bone. Hold the protection sleeve firmly and insert the 3.2 mm guide wire through the trocar. Under power, insert the 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 centerof the articular surface in both AP and ML views.



5. Open 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 through the protection sleeve to the bone. Drill through the calcaneus and talus until the opening drill exits the talus. Take care to avoid the tibial plafond.

Remove the 3.2 mm guide wire.



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


Reaming (Recommended)

6. Reaming (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 talusinto the medullary canal of the tibia.

ReamStarting with the 8.5 mm reaming head, ream in 0.5 mmincrements to a diameter of 1 mm larger than the naildiameter. Advance the reamer with steady, moderatepressure and do not force it. Partially retract the reameroften to clear debris from the medullary canal.

Note: All nails in the hindfoot arthrodesis nail expert system can be inserted over the 2.5 mm and 3.0 mm reaming rods with 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 rod during reamer extraction.


Inserting the Nail

1. Assemble insertion instruments

Instruments

03.008.007 Insertion Handle

03.010.092 Ball Hex Screwdriver, 8 mm

03.010.146 Cannulated Connecting Screw, with Internal Thread, for Percutaneous Insertion Handle

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

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

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


Inserting the Nail

2. Insert 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 insertion handle should be facing laterally.

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

If needed, use light, controlled hammer blows to seat the nail. Thread the driving cap onto the insertion handle.Lock the head of the slide/fixed hammer in place, usingthe 4.5 mm pin wrench to tighten the nut onto the threads below 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 position of the most critical locking option, ie, spiral blade position or talar screw.

Optional technique

Instrument

357.22 Hammer Guide

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


Distal Locking With Spiral Blade

Notes:• Distal locking first is recommended, to allow later

compression across 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 distal locking procedure may be started with this screw. However, this method limits positioning of calcaneus locking elements.

• Screw orientation can be estimated by placing a 3.2 mm guide wire through the appropriate holes of the insertion handle. With the foot in weight-bearing position, the guide wire should be aligned with the medial column through the talar hole, or the fourth ray when placed through the posterior to anterior hole.

1. Confirm 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 spiral blade 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.

Protection sleeveAiming arm

Threaded alignmentpin

Insertionhandle



1. Confirm nail and spiral blade position (continued)

Assemble the protection sleeve and wire guide and insertthe 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 calcaneus until the tip is flush with the anterior cortex. Confirm wire position radiographically. This position will determine the final position of the spiral blade.

2. Measure for spiral blade length

Instrument

03.010.083 Spiral Blade Measuring Device

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


3. Open posterior cortex

Instrument


Make an incision to split the Achilles tendon before inserting the spiral blade, to prevent damage to the soft tissue and risk of necrosis.

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

4. Attach adapter

Instrument

03.008.010 Aiming Arm Adapter

Attach the aiming arm adapter.




5. Insert spiral blade

Instruments

03.008.011 Spiral Blade Inserter

03.010.056 Slide/Fixed Hammer, 700 grams

357.34 Connecting Screw, for Titanium Spiral Blades

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

Pass the spiral blade assembly over the guide wire. Advance the spiral blade inserter through the aiming arm adapter, ensuring engagement of the inserter’s helical grooves with the 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 position to seat the spiral blade. Advancement should be monitored radiographically.

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

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

Remove the 3.2 mm guide wire.

6. Insert 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 distallocking element is desired.


Distal Locking With 6.0 mm Locking Screws

1. Confirm 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 inferior hole of the aiming arm. Make a vertical incision sufficient to retract and protect the skin edges to avoid compromising the wound. Insert the trocar to the bone. Remove the trocar.

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

Protection sleeve

Aiming arm

Threaded alignmentpin

Insertionhandle



2. Maintain aiming arm in position

Instruments

03.010.115 3.2 mm Guide Wire, 290 mm

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

3. Drill 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 intothe protection sleeve.

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

Confirm drill bit position radiographically.


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 sleeve and the measuring device with hook. Insert the measuring device into the protection sleeve.

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

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

4. Insert most distal locking screw

Instruments


03.010.108 StarDrive Screwdriver, T25, self-retaining

Insert the appropriate length 6.0 mm locking screw through the protection sleeve using the StarDrive Screwdriver.

Verify locking screw length under image intensification.

Remove the 3.2 mm aiming arm stabilization wire.




5. Insert second distal locking screw

Instrument


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


Talar Locking

1. Drill and determine length of talar locking screw

Instruments




03.010.056 Slide Fixed Hammer, 700 grams




03.010.070 4.2 mm Trocar, 210 mm

If compression across the subtalar joint is desired, removethe aiming arm by loosening the threaded alignment pin.Thread the driving cap to the insertion handle and use light hammer 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 the insertion 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 drill bit. Confirm drill bit position radiographically.

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.


Talar Locking

1. Drill and determine length of talar locking screw (continued)



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

Disassemble the depth gauge into two parts: the outer sleeve and the measuring device with hook. Insert themeasuring device into the protection sleeve. Ensure that the hook grasps the far cortex and the protection sleeve is flush to the bone. Read the measurement from the back of the protection sleeve, which indicates the appropriate length locking screw.

2. Insert talar screw

Instruments



Insert the appropriate locking screw through the protection sleeve using the StarDrive Screwdriver.

Verify locking screw length under image intensification.

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


Proximal Locking

1. Drill and determine length of proximal screw

Instruments





03.010.056 Slide Fixed Hammer, 700 grams




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 light hammer blows until the gap is sufficiently reduced. Reattach the 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 dynamic slot). The dynamic slot allows controlled dynamization of the bone fragments.

Insert the protection sleeve, drill sleeve and trocar assembly into 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.


Proximal Locking

1. Drill and determine length of proximal screw continued

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.



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

2. Insert proximal screws

Instruments



Insert the appropriate 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.


End Cap Insertion

1. Insert 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 StarDrive Screwdriver.

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

Notes:• To minimize the chance of cross-threading, turn the

end cap counterclockwise until the threads of the end cap align with the threads of the nail.

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


Implant Removal (Optional)

1. Remove end cap

Instrument


Clear the StarDrive Recesses of the end cap and the locking implants of any tissue ingrowth. Remove the end cap, using the StarDrive Screwdriver.

2. Remove 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.


3. Remove locking screws

Instruments



Remove all but the most proximal locking screw.

Attach the extraction screw to the nail.

4. Remove 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.

Implant Removal (Optional)


Implant Specifications

Titanium Hindfoot ArthrodesisCannulated Nail–EX• Right and left designs• Cannulated for use over all DePuy 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) or medial side

• Static transverse locking (6.0 mm locking screw)

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

133.5 mm126.5 mm

100 mm

40 mm

22.5 mm11.5 mm

160 mm

9 mm dia.


Titanium Hindfoot Arthrodesis Cannulated Nail–EX, sterile

10 mm diameterLength (mm) Right Left

150 04.008.010S 04.008.060S180 04.008.016S 04.008.066S240 04.008.028S 04.008.078S


150 04.008.210S 04.008.260S

180 04.008.216S 04.008.266S

240 04.008.228S 04.008.278S


150 04.008.310S 04.008.360S

180 04.008.316S 04.008.366S

240 04.008.328S 04.008.378S

Implants


5.0 mm Titanium Locking Screws◊, with T25 StarDrive Recess, 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)

04.005.516 2604.005.518 2804.005.520 3004.005.522 3204.005.524 3404.005.526 3604.005.528 3804.005.530 4004.005.532 4204.005.534 4404.005.536 4604.005.538 4804.005.540 5004.005.542 5204.005.544 5404.005.546 56

Length (mm)

04.005.548 5804.005.550 6004.005.552 6204.005.554 6404.005.556 6604.005.558 6804.005.560 7004.005.562 7204.005.564 7404.005.566 7604.005.568 7804.005.570 8004.005.575 8504.005.580 9004.005.585 9504.005.590 100

Implants

◊ Available nonsterile or sterile-packed. Add “S” to catalog number to order sterile product.*Ti-6Al-7Nb alloy


Implants

Length (mm)

04.005.616† 2604.005.618† 2804.005.620† 3004.005.622† 3204.005.624† 3404.005.626† 3604.005.628† 3804.005.630† 4004.005.632† 4204.005.634† 4404.005.636† 4604.005.638 4804.005.640 5004.005.642 5204.005.644 5404.005.646 56

Length (mm)

04.005.648 5804.005.650 6004.005.654 6404.005.658 6804.005.662 7204.005.666 7604.005.670 8004.005.675 8504.005.680 9004.005.685 9504.005.690 10004.005.691 10504.005.692 11004.005.693 11504.005.694 12004.005.695 125

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

◊Available nonsterile or sterile-packed. Add “S” to catalog number to order sterile product.*Ti-6Al-7Nb alloy†Also available.


Implants

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 4504.013.042 5004.013.043 5504.013.044 6004.013.045 6504.013.046 7004.013.047 7504.013.048 8004.013.049 8504.013.050 9004.013.051 9504.013.052 100

◊ Available nonsterile or sterile-packed. Add “S” to catalog number to order sterile product.* Ti-6Al-7Nb alloy


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

Implants

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


Instruments

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

03.008.011 Spiral Blade Inserter for Hindfoot Arthrodesis Nail–EX





Instruments





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 mm for IM Nails


Instruments

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

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

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


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


Instruments

03.010.112 Holding Sleeve, with Locking Device

03.010.115 3.2 mm Guide Wire, 290 mm

03.010.146 Cannulated Connecting Screw, with Internal Thread, for Percutaneous Insertion Handle


321.20 Ratchet Wrench, 11 mm width across flats




Instruments

357.128 13.0 mm /3.2 mm Trocar


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


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

Note: For additional information, please refer to package insert.

Hindfoot Arthrodesis Nail–EX Implant 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 Arthrodesis Nail–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 Cannulated Hindfoot Arthrodesis Nail–EX

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

03.008.011 Spiral Blade Inserter for Hindfoot Arthrodesis Nail–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

For detailed cleaning and sterilizationinstructions, please refer towww.synthes.com/cleaning-sterilization orsterilization instructions, if provided.




Instruments03.010.072 Depth Gauge, for Locking Screws to 100 mm for 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 Spiral Blade Aiming Arm

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


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

03.010.112 Holding Sleeve, with Locking Device

03.010.115 3.2 mm Guide Wire, 290 mm, 5 ea.

03.010.146 Cannulated Connecting Screw, with Internal Thread, for Percutaneous Insertion Handle, 2 ea.


321.20 Ratchet Wrench, 11 mm width across flats

351.27◊ 13.0 mm Cannulated Drill Bit, 300 mm


357.128 13.0 mm/3.2 mm Trocar


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, 5 ea.




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.

6.0 mm Titanium Locking Screws◊, with T25 StarDrive Recess,

for IM Nails, 2 ea.

Titanium Spiral Blades◊ (gold)

Titanium End Caps◊, with T25 StarDrive Recess, for Hindfoot Arthrodesis 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)

04.005.516 2604.005.518 2804.005.520 3004.005.522 3204.005.524 3404.005.526 3604.005.528 3804.005.530 4004.005.532 4204.005.534 4404.005.536 4604.005.538 4804.005.540 5004.005.542 5204.005.544 5404.005.546 56

Length (mm)

04.005.638 4804.005.640 5004.005.642 5204.005.644 5404.005.646 5604.005.648 5804.005.650 6004.005.654 6404.005.658 6804.005.662 7204.005.666 76

Length (mm)

04.013.041 4504.013.042 5004.013.043 5504.013.044 6004.013.045 6504.013.046 70 04.013.047 7504.013.048 8004.013.049 8504.013.050 9004.013.051 9504.013.052 100

Length (mm)

04.005.548 5804.005.550 6004.005.552 6204.005.554 6404.005.556 6604.005.558 6804.005.560 7004.005.562 7204.005.564 7404.005.566 7604.005.568 7804.005.570 8004.005.575 8504.005.580 9004.005.585 9504.005.590 100

Length (mm)

04.005.670 8004.005.675 8504.005.680 9004.005.685 9504.005.690 10004.005.691 10504.005.692 11004.005.693 11504.005.694 12004.005.695 125



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 and extension, 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)

04.005.616 2604.005.618 2804.005.620 3004.005.622 3204.005.624 3404.005.626 3604.005.628 3804.005.630 4004.005.632 4204.005.634 4404.005.636 46

© DePuy Synthes 2007–2017. All rights reserved.DSUS/TRM/0916/1044 6/17 DV

Synthes USA, LLC 1101 Synthes AvenueMonument, CO 80132

Manufactured or distributed by:Synthes USA Products, LLC 1302 Wrights Lane EastWest Chester, PA 19380

To order (USA): 800-523-0322 To order (Canada): 855-946-8999

Note: For recognized manufacturer, refer to the product label.

www.depuysynthes.com

Limited Warranty and Disclaimer: DePuy Synthes products are sold with a limited warranty to the original purchaser against defects in workmanship and materials. Any other express or implied warranties, including warranties of merchantability or fitness, are hereby disclaimed.

Please also refer to the package insert(s) or other labeling associated with the devices identified in this surgical technique for additional information.

CAUTION: Federal Law restricts these devices to sale by or on the order of a physician.

Some devices listed in this surgical technique may not have been licensed in accordance with Canadian law and may not be for sale in Canada. Please contact your sales consultant for items approved for sale in Canada.

Not all products may currently be available in all markets.

Documents

Expert Nailing System Titanium Cannulated Hindfoot ...synthes.vo.llnwd.net/o16/LLNWMB8/US Mobile/Synthes North America... · 4 DePuy Synthes Titanium Cannulated Hindfoot Arthrodesis