TRIGEN 71754022Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010514288), received between Sep 20, 2020 and Sep 20, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Failure to Align” (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

Recent adverse event reports

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

• InjurySep 20, 2020Failure to Align; Failure to Align

  IT WAS REPORTED THAT WHEN USING THE SN DEVICE TRIGEN SCREW FOR HUMERAL NAILING, THE FIRST SCREW USED FOR DISTAL SCREWING BECAME UNSUITABLE FOR THE SCREWDRIVER THAT IS NORMALLY DESIGNED TO LOCK INTO THE SCREW. THE SCREW WHEN USED WAS THEN LOST INSIDE THE PATIENT'S ARM. IT WAS DIFFICULT TO REMOVE IT. AT FIRST, THE TEAM THOUGHT THAT THE SCREWDRIVER HAD BEEN MISUSED. THE PROCEDURE CONTINUED WITHOUT PROBLEMS FOR THE INSERTION OF THE OTHER SCREWS, UNTIL THE FIRST SCREW REMOVED WAS REUSED. THE SAME PROBLEM OCCURRED AGAIN: SCREW LOST IN THE PATIENT. THIS SCREW WAS SUCCESSFULLY REMOVED AGAIN. AFTER FURTHER OBSERVATION AND HANDLING, IT WAS FOUND THAT THE SCREW APPEARS TO HAVE A DEFECT THAT CAUSES IT TO DETACH AT AN ANGLE FROM THE SCREWDRIVER TO WHICH IT IS SUPPOSED TO BE FIRMLY ATTACHED. THERE WERE NO CONSEQUENCES FOR THE PATIENT DESPITE THE LONGER OPERATING TIME AND THE RISK OF INJURY DURING THE SEARCH FOR THE SCREW. SMITH AND NEPHEW BACKUP DEVICE WAS USED. IT IS UNKNOWN HOW LONG WAS THE DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10558349 ↗

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, 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