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TRIGEN 71655029Recalls & reported problems

Smith & Nephew, Inc. · TRIGEN META TIBIAL NAIL 8.5MM X 29CM · 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 03596010596529), received between Jul 11, 2023 and Jul 11, 2023 — classified as 1 injury.

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

  • Fracture1

Patient problems

  • Failure of Implant1
  • Foreign Body In Patient1

Recent adverse event reports

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

  • InjuryJul 11, 2023Fracture; Fracture

    IT WAS REPORTED THAT, A REVISION SURGERY WAS PERFORMED ON (B)(6)2023, FOR A META-NAIL TIBIAL 8.5MM X 29CM THAT WAS IMPLANTED ON (B)(6)2015. DURING THE REVISION, IT WAS FOUND THE NAIL WAS BROKEN AT THE DISTAL POSITION. THE PIECE COULD NOT BE RETRIEVED AND REMAINS INSIDE THE PATIENT. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

    Patient problems: Failure of Implant; Foreign Body In Patient

    MAUDE report 17302991 ↗

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.