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TRIGEN 71655230Recalls & reported problems

Smith & Nephew, Inc. · TRIGEN META TIBIAL NAIL 11.5MM X 30CM · 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 03596010585639), received between Jul 19, 2018 and Jul 19, 2018 — 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

  • Injury1

Recent adverse event reports

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

  • InjuryJul 19, 2018Break; Break

    IT WAS REPORTED THAT WHEN INSERTING THE NAIL, THERE WERE NO PROBLEMS, BUT WHEN A CENTIMETER WAS MISSING TO FINISH ENTERING IT, DOCTOR TOOK THE NAIL FROM THE PART OF THE ARCH WITH HIS HAND, AND IT (THREAD OF THE NAIL) WAS BROKEN WHEN TURNING IT VERY EASILY. IN ORDER TO REMOVE IT, IT WAS NECESSARY TO OPEN THE FOCUS OF THE FRACTURE AND IMPACT IT UPWARDS, IN THIS PROCESS, THE LINES OF THE FRACTURE WERE DISPLACED AND THE TIBIA WAS OPENED IN SEVERAL PARTS; FOR THAT REASON, IT WAS VERY DIFFICULT TO PLACE THE NAIL AGAIN. IT WAS NECESSARY TO PLACE CERCLAGES WITH WIRE AFTER RE-FRACTURING THE TIBIA, THE FRACTURE WAS NOT EASILY CORRECTED ONLY WITH THE NAIL. THE PROCEDURE WAS DELAYED FOR 5 HOURS.

    Patient problems: Injury

    MAUDE report 7704891 ↗

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.