TRIGEN 71655234Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010585653), received between May 4, 2021 and Sep 29, 2024 — 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

Recent adverse event reports

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

• InjurySep 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, FOLLOWING AN INTRAMEDULLARY NAIL FIXATION OF A DISPLACED BIMALLEOLAR FRACTURE OF RIGHT TIBIA PERFORMED ON (B)(6) 2020, THE PATIENT REQUIRED AN ADDITIONAL SURGERY ON (B)(6) 2020 DUE TO RIGHT TIBIA PAINFUL ORTHOPEDIC HARDWARE AND RIGHT DISTAL THIRD TIBIA INCOMPLETE UNION. THE HARDWARE WAS REMOVED. THIS INFORMATION WAS COLLECTED RETROSPECTIVELY AS PART OF A POST-MARKET CLINICAL FOLLOW UP (PMCF) ACTIVITY AND IS PROVIDED IN AN ANONYMIZED FORMAT; THEREFORE, NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Implant Pain; Nonunion/Delayed-union Bone Fracture

  MAUDE report 20329575 ↗
• InjuryMay 4, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TRAUMA SURGERY A META-NAIL TIBIAL 11.5MM X 34CM WAS INTRODUCED WITH NO ISSUES. WHEN REACHING THE FRACTURE, THE PHYSICIAN STARTED TO ROTATE THE NAIL BY THE PIECE THAT CARRIES THE NAIL AND, SUDDENLY, THE PIECE BROKE. THEN, BY USING A HOOK AND THROUGH THE HOLES OF THE NAIL IT COULD BE REMOVED FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF GREATER THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. THE PATIENT IS STABLE AND NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11773657 ↗