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TRIGEN 71655236Recalls & reported problems

Smith & Nephew, Inc. · TRIGEN META TIBIAL NAIL 11.5MM X 36CM · Class 2 · Implant

Adverse event reports
2
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010585677), received between Feb 17, 2019 and Mar 14, 2019 — classified as 1 injury, 1 malfunction.

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
  • Fracture1

Patient problems

  • Injury1
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryMar 14, 2019Break; Break

    A SECOND SURGERY WAS PERFORMED TO IMPLANT A NON-FRACTURED META-NAIL TIBIAL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Patient problems: Injury

    MAUDE report 8421187 ↗
  • MalfunctionFeb 17, 2019Fracture; Fracture

    IT WAS REPORTED THAT DURING THE SURGICAL PROCEDURE, IT WAS NOTICED THAT THE PROXIMAL PART OF THE 11.5MMX36 CM TIBIA NAIL WAS FRACTURED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8346580 ↗

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.