TRIGEN 71645140Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010541352), received between Mar 19, 2018 and Mar 19, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K040929, 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

Recent adverse event reports

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

• InjuryMar 19, 2018Fracture; Fracture

  IT WAS REPORTED THAT DURING A TRAUMA SURGERY WHILE PLACING THE FINAL NAIL AFTER THE SECOND IMPACT, THE PROXIMAL TABS OF THE NAIL WERE OPENED AND BROKEN, THE NAIL WAS INSIDE THE PATIENT. WITH MANUAL MOVEMENTS AND A LOT OF CAUTION, THE DOCTOR REMOVED THE NAIL FROM THE PATIENT. PROCEDURE WAS COMPLETED WITH A NEW IMPLANT AND NO INJURY WAS REPORTED. DELAY WAS ABOVE 30 MINUTES DUE TO THE REMOVAL OF THE NAIL AND THE NEW IMPLANTATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7349010 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K040929, K210980. One submission often covers many models, so check the product and lot details in each record.

• Z-2456-2026 · Mar 16, 2026 · Open, Classified
  TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816
• Z-1806-2025 · Mar 18, 2025 · Open, Classified
  META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690
• Z-2443-2023 · Jul 24, 2023 · Open, Classified
  TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT, REF 71647336, Femur nail
• Z-2444-2023 · Jul 24, 2023 · Open, Classified
  TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT, REF 71647340, Femur nail