TRIGEN 71648338Recalls & reported problems
Smith & Nephew, Inc. · TRIGEN TROCHANTERIC ANTEGRADE NAIL ROSE 11.5MM X 38CM 130 DEGREE RIGHT · 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 03596010501264), received between Jul 26, 2022 and Jul 26, 2022 — classified as 1 injury.
4 other recalls cover devices cleared under the same FDA submission (K040462, K210980); they may or may not involve this specific model.
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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Fall1
- Hip Fracture1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER AN INTERNAL FIXATION SURGERY WAS PERFORMED ON 2008, THE PATIENT SUFFERED A PERIPROSTHETIC FRACTURE AFTER A FALL. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2022, WHERE THE 11.5 X 38 130 D TAN RT ROSE, THE NAIL CAP 10MM AND TWO (2) UNKNOWN TRIGEN TAN/FAN NAIL SCREW WERE EXPLANTED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.
Patient problems: Fall; Hip Fracture
MAUDE report 15108934 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K040462, K210980. One submission often covers many models, so check the product and lot details in each record.
- Z-2456-2026 · Mar 16, 2026 · Open, ClassifiedTRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816
- Z-1806-2025 · Mar 18, 2025 · Open, ClassifiedMETA-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690
- Z-2443-2023 · Jul 24, 2023 · Open, ClassifiedTRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT, REF 71647336, Femur nail
- Z-2444-2023 · Jul 24, 2023 · Open, ClassifiedTRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT, REF 71647340, Femur nail
Other ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES devices
- NA 03.033.001Synthes GmbH · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES265 reports
- GAMMA 3125-1180SStryker GmbH · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES249 reports
- NA 03.037.026Synthes GmbH · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES225 reports
- PRECICE® Intramedullary Limb Lengthening System LSC5-075Nuvasive Specialized Orthopedics, Inc. · Rod, Fixation, Intramedullary And Accessories4 recalls2 reports
- PRECICE® Intramedullary Limb Lengthening System LSC5-045Nuvasive Specialized Orthopedics, Inc. · Rod, Fixation, Intramedullary And Accessories4 recalls1 report
- TRIGEN 71674067Smith & Nephew, Inc. · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES201 reports
- PRECICE® Intramedullary Limb Lengthening System LSC5-050Nuvasive Specialized Orthopedics, Inc. · Rod, Fixation, Intramedullary And Accessories4 recalls1 report
- PRECICE Intramedullary Limb Lengthening System LSB5-075Nuvasive Specialized Orthopedics, Inc. · Rod, Fixation, Intramedullary And Accessories4 recalls0 reports
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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