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TRIGEN 71655240Recalls & reported problems

Smith & Nephew, Inc. · TRIGEN META TIBIAL NAIL 11.5MM X 40CM · Class 2 · Implant

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

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010585714), received between Oct 23, 2019 and Oct 31, 2019 — classified as 2 injuries.

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
  • Insufficient Device Problem Information1

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.

  • InjuryOct 31, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED THAT AS A RESULT OF NON-UNION OF A FRACTURE DR. REMOVED A TIBIAL NAIL AND DID AN ORIF USING AN EVOS PLATE. HE WAS CONFIDENT THERE WAS NO FAILURE OF THE IMPLANT. REVISION SURGERY REQUIRED TO IMPROVE PT OUTCOME. THE DEVICE DID NOT ACTUALLY CAUSE ANY HARM TO THE PATIENT.

    Patient problems: Injury

    MAUDE report 9263940 ↗
  • InjuryOct 23, 2019Break; Break

    IT WAS REPORTED THAT DURING THE PROCEDURE, DR. (B)(6) WERE TRIED TO REALIGN THE NAIL WHEN INSERTING IT INTO THE PATIENT. DURING THAT PROCESS THE PROXIMAL END OF THE NAIL WAS SHEERED OFF. NO MORE INFORMATION AVAILABLE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9227133 ↗

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.