TRIGEN 71653046Recalls & reported problems

Smith & Nephew, Inc. · TRIGEN META RETROGRADE FEMORAL NAIL 10MM X 46CM · Class 2 · Implant

All models of TRIGEN (381)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010548252), received between Sep 29, 2024 and Sep 29, 2024 — classified as 1 injury.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Adverse Event Without Identified Device or Use Problem1

Patient problems

Muscle/Tendon Damage1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjurySep 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, FOLLOWING AN INTRAMEDULLARY NAIL ARTHRODESIS PERFORMED ON (B)(6) 2021 DUE TO RIGHT TKA INFECTION, THE PATIENT SUSTAINED A QUADRICEPS TENDON RUPTURE ON (B)(6) 2021 THAT REQUIRED THE REMOVAL OF THE NAIL WITH A FREE FLAP RECONSTRUCTION REVISION. THIS INFORMATION WAS COLLECTED RETROSPECTIVELY AS PART OF A POST-MARKET CLINICAL FOLLOW UP (PMCF) ACTIVITY AND IS PROVIDED IN AN ANONYMIZED FORMAT; THEREFORE, NO FURTHER INFORMATION AVAILABLE.
Patient problems: Muscle/Tendon Damage
MAUDE report 20329563 ↗

Device details

UDI-DI	`03596010548252`
Brand	TRIGEN
Model	71653046
Company	Smith & Nephew, Inc.
Product code	JDS · NAIL, FIXATION, BONE
Class	Class 2
FDA submission	None listed
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	Nov 28, 2025

Device type (GMDN): Femur intramedullary nail

A rigid rod made of metal or other material intended to be implanted into the intramedullary canal of the femur to immobilize the ends of a fractured bone in position to promote healing; it is not dedicated to extension beyond the joint to an adjacent bone (i.e., not dedicated to arthrodesis/joint fusion). It may be a locked or unlocked model and may include components to assist fixation of more proximal or distal conditions. This is a single-use device.

Other NAIL, FIXATION, BONE devices

NA 03.043.024
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234 reports
NA 03.010.440
Synthes GmbH · NAIL, FIXATION, BONE
70 reports
TRIGEN 71676627
Smith & Nephew, Inc. · NAIL, FIXATION, BONE
1 recall2 reports
TRIGEN 71676628
Smith & Nephew, Inc. · NAIL, FIXATION, BONE
1 recall0 reports
NA 03.043.018
Synthes GmbH · NAIL, FIXATION, BONE
33 reports
TRIGEN 71675383
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29 reports
NA 03.010.441
Synthes GmbH · NAIL, FIXATION, BONE
27 reports
NA 04.043.240S
Synthes GmbH · NAIL, FIXATION, BONE
24 reports

All NAIL, FIXATION, BONE devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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