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TRIGEN 71655330Recalls & reported problems

Smith & Nephew, Inc. · TRIGEN META TIBIAL NAIL 13MM X 30CM · Class 2 · Implant

Data updated Oct 13, 2026 from official FDA records · Editorial policy

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010612908), received between Feb 18, 2020 and Feb 18, 2020 — classified as 1 malfunction.

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

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionFeb 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT DURING SURGERY, AFTER HITTING THE NAIL WITH A HAMMER FOR INSERTION, THE TIBIAL DISTAL CANOPY WAS DAMAGED. SURGEON DID NOT NOTICED THAT THE NAIL STUCK THE TIBIAL BONE. IT WAS CONFIRMED WITH THE X-RAY IMAGE AND THE CT IMAGE AFTER THE OPERATION THAT THE NAIL STUCK OUT FROM BOTH SIDES OF THE TIBIAL BONE. THERE WAS A 15 MINUTES DELAY. ON (B)(6) 2020, THE PATIENT COMPLAINED OF PAIN. THE NAIL IS STILL INSIDE THE PATIENT. NO PLAN FOR REVISION SURGERY AT THIS MOMENT. THE SURGEONS THINK THIS ISSUE OCCURRED DUE TO THEIR MISTAKES OF NAIL LENGTH CHOICE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9720548 ↗

Other NAIL, FIXATION, BONE devices

All NAIL, FIXATION, BONE devices →

Sources and updates

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