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TRIGEN 71655239Recalls & reported problems

Smith & Nephew, Inc. · TRIGEN META TIBIAL NAIL 11.5MM X 39CM · 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 03596010585707), received between Jun 27, 2022 and Jun 27, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Mechanical Jam” (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

  • Mechanical Jam1

Patient problems

  • Pain1

Recent adverse event reports

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

  • InjuryJun 27, 2022Mechanical Jam; Mechanical Jam

    IT WAS REPORTED THAT, AFTER A META-NAIL TIBIAL 11.5MM X 39CM HAD BEEN IMPLANTED ON AN UNSPECIFIED DATE, THE PATIENT STARTED EXPERIENCING PAIN. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 WHILE ATTEMPTING TO REMOVE THE NAIL, THE NAIL CAP WAS JAMMED TO THE NAIL AND IT COULD NOT BE REMOVED. THE PROCEDURE LASTED 6 HOURS UNTIL THE NAIL WAS REMOVED BY ORDINARY METHODS. PATIENT HAS BEEN DISCHARGED FROM THE HOSPITAL AND IS CURRENTLY DOING FINE.

    Patient problems: Pain

    MAUDE report 14830993 ↗

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.