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COMPREHENSIVE SOLUTION FOR THE TREATMENT OF FEMORAL SHAFT FRACTURES FEMORAL RECON NAIL SYSTEM Choice of Greater Trochanter and Piriformis Fossa Approaches

FEMORAL RECON NAIL SYSTEMsynthes.vo.llnwd.net/o16/LLNWMB8/US Mobile/Synthes...The Femoral Recon Nail System is intended for treatment of fractures in adults and adolescents (12-21)

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Page 1: FEMORAL RECON NAIL SYSTEMsynthes.vo.llnwd.net/o16/LLNWMB8/US Mobile/Synthes...The Femoral Recon Nail System is intended for treatment of fractures in adults and adolescents (12-21)

COMPREHENSIVE SOLUTION FOR THE TREATMENT OF FEMORAL SHAFT FRACTURES

FEMORAL RECON NAIL SYSTEM

Choice of Greater Trochanter and Piriformis Fossa Approaches

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The FRN is an integrated nailing system designed to adapt to multiple surgical approaches.

As part of the DePuy Synthes portfolio the FRN leverages the

global success and learnings of the EXPERT NAIL® System

and TFN-ADVANCED® Proximal Femur Nailing System (TFNA).

The FRN System provides the choice of Piriformis Fossa (PF)

and Greater Trochanter (GT) entry points and anatomical

nail designs to support surgical preferences and facilitate

hospital standardization.

The FRN was designed to provide COMPREHENSIVE SURGICAL OPTIONS, to address ANATOMICAL FIT and to REDUCE PROCEDURAL COMPLEXITY.

INTRODUCING THE DEPUY SYNTHES FEMORAL RECON NAIL SYSTEM (FRN)

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The FRN instrumentation includes features designed to reduce surgical complexity facilitating intraoperative visualization, implant positioning and alignment as well as ease of use for OR staff.

REDUCED PROCEDURAL COMPLEXITY

Nail designed to better fit patient anatomy and help avoid impinging anterior cortex compared to nails with a larger radius of curvature.1,2

DESIGNED FOR ANATOMICAL FIT

The DePuy Synthes Femoral Recon Nail System offers an extensive range of surgical entry points and locking options to meet more surgeons’ needs for femoral shaft fractures.

COMPREHENSIVE SURGICAL OPTIONS

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COMPREHENSIVE SURGICAL OPTIONSThe DePuy Synthes Femoral Recon Nail Systemoffers an extensive range of surgical entry pointsand locking options to meet more surgeons’ needsfor femoral shaft fractures.

Equipped with four distal locking options, including an oblique distal hole offset 10° to better target bone in the condyles and an A/P hole that provides an optional purchase point.

DISTAL LOCKING OPTIONS

Designed to provide angular and axial stability.3

COMPATIBLE WITH THE ANGULAR STABLE LOCKING SYSTEM (ASLS)

DISTAL DYNAMIZATION OPTION

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Choice of standard and reconstruction locking modes allows for the treatment of a variety of femoral fracture patterns and locations.

PROXIMAL LOCKING OPTIONS

Greater Trochanter and Piriformis Fossa entry point nail designs to accommodate varying patient anatomies and surgeon preference.

ENTRY POINT SELECTION

Top view Top view

PROXIMAL DYNAMIZATION OPTION

DISTAL DIAMETERS LENGTHS MATERIAL

9 and 10 mm 280-480 mm (20 mm increments)Titanium Alloy (TAN)

11, 12 and 14 mm 300-480 mm (20 mm increments)

All nails 13 mm proximal diameter (14 mm for 14 mm distal diameter nails) Recon Screws CCD Angle is 130°

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DESIGNED FOR ANATOMICAL FITNail designed to better fit patient anatomy.

Short proximal nail end designed to reduce the risk of nail prominence compared with nails with a longer nail end.2

Gold = DePuy Synthes PF Femoral Recon Nail

Dashed = Simulated competitor PF nail with longer nail end

Simulated competitor nail

Femoral Recon Nail shape (1.0m anatomic bow) based on multi-ethnic 3-D computational study designed to better fit patient anatomy and to help avoid impinging anterior cortex compared to nails with larger radius of curvature.1

Far AnteriorAnteriorCenterPosterior Far Posterior

Gold = Femoral Recon Nail 1 m radius of curvature

DePuy Synthes

Blue = simulated nail with 1.5 m radius of curvature

Distal nail tip position for 1.0 m ROC FRN compared to 1.5 m ROC nail1

Far Anterior

21%

59%

FRN (N=82)

1.5 m ROC Femoral Nail (N=51)*

Anterior

24%

25%

Center

35%

14%

Posterior

17%

2%

Far Posterior

4%

0%

*Test data on Gamma3® femoral nail, Stryker®1

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REDUCED PROCEDURAL COMPLEXITY

The FRN instrumentation includes features designed to reduce surgical complexity facilitating intraopera-tive visualization, implant positioning and alignment as well as ease of use for OR staff.

QUICK CLICK®

Self-Retaining Technology designed to facilitate attachment of nail to insertion handle.

Radiolucent insertion handle with radiographic indicators supports x-ray visualization and assists with guide wire placement.

RADIOLUCENT INSTRUMENTATION

Reaming Protection System designed to protect the proximal metaphysis from lateralization during incremental reaming.

REAMING PROTECTION SYSTEM

Shared instrumentation platform with lower extremities shaft nails and TFN-ADVANCED® Proximal Femur Nailing System (TFNA) can reduce inventory complexity and promote familiarity with the instrumentation.

SHARED INSTRUMENTATION

Page 8: FEMORAL RECON NAIL SYSTEMsynthes.vo.llnwd.net/o16/LLNWMB8/US Mobile/Synthes...The Femoral Recon Nail System is intended for treatment of fractures in adults and adolescents (12-21)

The Femoral Recon Nail System is intended for treatment of fractures in adults and adolescents (12-21) in which the growth plates have fused. Specifically, the system is indicated for:

• Subtrochanteric fractures

• Ipsilateral neck/shaft fractures

• Femoral shaft fractures

• Impending pathologic fractures

• Malunions and nonunions

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) and surgical technique associated with the devices identified in this brochure for additional information.

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

Some devices listed in this brochure may not have been licensed in accordance with the 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.

Manufactured or distributed by:

To order (USA): 800-523-0322 To order (Canada): 844-243-4321

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

Synthes USA Products, LLC 1302 Wrights Lane East West Chester, PA 19380

Synthes USA, LLC 1101 Synthes Avenue Monument, CO 80132

1. DePuy Synthes Trauma. Data on file. Analysis - Anatomical Study. 0000271671. 2017

2. DePuy Synthes Trauma. Data on file. Analysis - Femoral Recon Nail, Proximal Nail End. 0000271887. 2017

3. Stoffel K, Schwieger K. AO Foundation: Biomechanical investigation on angular stable locking of the Expert Tibia Nail, 2007

REFERENCES

© DePuy Synthes 2018. All rights reserved.DSUS/TRM/1117/1690(1) 03/18

The third-party trademarks used herein are the trademarks oftheir respective owners.