TRIGEN 71770816Recalls & reported problems
Smith & Nephew, Inc. · TRIGEN HUMERAL NAIL 8/7MM X 16CM PROXIMAL BENT · 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 03596010514387), received between Feb 15, 2022 and Feb 15, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (1 report).
4 other recalls cover devices cleared under the same FDA submission (K032722, 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
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 15, 2022Break; Break
IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE SURGEON HAD ALREADY DECIDED TO PLACE A TRIGEN HUMERAL NAIL 8/7MM X 16CM PROXIMAL BENT, BUT WHEN PLACING IT THE LATERAL CORTEX BROKE, AND HE DECIDED TO PLACE A LONGER ONE, WHICH WAS 8/7MM X 24MM. NO DELAY OCCURRED AS A CONSEQUENCE OF THIS PROBLEM. PATIENT CURRENT HEALTH STATUS IS GOOD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13532959 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K032722, 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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