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TRIGEN 71655033Recalls & reported problems

Smith & Nephew, Inc. · TRIGEN META TIBIAL NAIL 8.5MM X 33CM · 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 03596010585486), received between Apr 16, 2023 and Apr 16, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Failure to Align” (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

  • Failure to Align1

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.

  • InjuryApr 16, 2023Failure to Align; Failure to Align

    IT WAS REPORTED THAT DURING TRAUMA SURGERY, THE MEDULLARY CANAL HAD BEEN PREVIOUSLY RIMMED AND ONE (1) META-NAIL TIBIAL 8.5MM X 33CM WAS PLACED, AN ATTEMPT WAS MADE TO BLOCK DISTALLY WITH SURESHOT AND UNDER FLUOROSCOPY BUT IT WAS NOT POSSIBLE TO PLACE THE SCREW AFTER SEVERAL ATTEMPTS. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A DIFFERENT SIZE S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16748735 ↗

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.