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TRIGEN 71653232Recalls & reported problems

Smith & Nephew, Inc. · TRIGEN META RETROGRADE FEMORAL NAIL 11.5MM X 32CM · Class 2 · Implant

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 03596010548412), received between Jun 28, 2021 and Jun 28, 2021 — classified as 1 injury.

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

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Crack1

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.

  • InjuryJun 28, 2021Crack; Crack

    IT WAS REPORTED THAT, DURING A TRAUMA SURGERY WHILE THE INSTRUMENT WAS INSIDE OF THE PATIENT, AFTER INSERTING THE DISTAL SCREWS AND CONFIRM THE ROTATION THERE WAS A SOUND. HOWEVER, THE SURGERY CONTINUED; WHEN SETTING THE END CAP AND IT COULD NOT BE INSERTED. THEN, IT WAS CONFIRMED UNDER IMAGE THAT THERE WAS A CRACK ON THE END OF THE META RETRO FEM NAIL 11.5 X 32 AND IT WAS REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SIGNIFICANT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. PATIENT WAS NOT HARMED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12076233 ↗

Other NAIL, FIXATION, BONE devices

All NAIL, FIXATION, BONE devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.