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TRIGEN 71655238Recalls & reported problems

Smith & Nephew, Inc. · TRIGEN META TIBIAL NAIL 11.5MM X 38CM · 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 03596010585691), received between Mar 14, 2021 and Mar 14, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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

  • 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.

  • InjuryMar 14, 2021Break; Break

    IT WAS REPORTED THAT A TRIGEN TIBIAL META-NAIL 11.5 X 38 BROKE AT PROXIMAL TIP OF NAIL. THE PIECES WERE RETRIEVED WITH A FORCEPS. THE PROCEDURE WAS COMPLETED WITH A BACK UP DEVICE. NO OTHER INJURIES WERE REPORTED AND NO SIGNIFICANT DELAYS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11478940 ↗

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.