TRIGEN 71655135Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010585578), received between May 2, 2023 and Sep 29, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Handling Problem” (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 3 most recent of 3 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, AFTER A LEFT TIBIAL ORIF PROCEDURE WITH PLACEMENT OF ANTIBIOTIC CEMENT SPACER PERFORMED ON (B)(6) 2019 DUE TO INFECTION, THE PATIENT EXPERIENCED NON-UNION ON AN UNKNOWN DATE. NO FURTHER DETAILS ARE AVAILABLE REGARDING THE MEASURES TAKEN TO TREAT THIS SYMPTOM. 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: Nonunion/Delayed-union Bone Fracture

  MAUDE report 20329515 ↗
• InjurySep 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER AN IMN PERFORMED ON (B)(6) 2020 DUE TO A MOTORCYCLE ACCIDENT WHERE THE RIGHT TIBIA FRACTURED, THE PATIENT UNDERWENT AN IMN EXCHANGE WITH ALLOGRAFT ON (B)(6) 2021 DUE TO PAINFUL NON-UNION. 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: Nonunion/Delayed-union Bone Fracture

  MAUDE report 20329497 ↗
• MalfunctionMay 2, 2023Device Handling Problem; Device Handling Problem

  IT WAS REPORTED THAT DURING A TRAUMA SURGERY A SEMI-EXTENDED TECHNIQUE WAS PERFORMED, STARTING WITH CHANNEL RHYME, USING THE SEMIEXTENDED ENTRY TUBE WITH THE CLAMPING HANDLE. THE SURGEON PROCEEDED TO INSERT THE META-NAIL TIBIAL 10MM X 35CM MANUALLY, THEN HE STRONGLY IMPACTED IT WITH THE HAMMER IMPACTOR AND IT WAS FOUND THAT THE HANDLE WAS RELEASED FROM THE GUIDE. THE SURGEON WAS INFORMED AND HE SAID THAT AT THE END HE WOULD REMOVED IT. SALES REP SUGGESTED TO CHECK BEFORE CONTINUING AND IF POSSIBLE REMOVE THE NAIL A LITTLE TO KNOW WHY THE HANDLE CAME LOOSE AND WHY THE GUIDE WAS BEING INTRODUCED, BUT THE SURGEON IGNORED IT AND REPEATED THAT AFTER INSERTING THE NAIL HE WOULD CHECK. EACH TIME IT WAS EVIDENT THAT THE GUIDE DID NOT TOUCH THE PATELLAR REGION, SALES REP SHOWED HIM WHAT HAPPENED AT THE END OF IMPACTING THE NAIL TO ITS POINT, THE SPECIALIST NOTICED THAT THE GUIDE ENTERED THE MEDULLARY CANAL AND ITS REMOVAL WAS NOT SO EASY, HE HIT THE ARC OF CONNECTION OF THE SEMIEXTENDED DRILL GUIDE, WHERE THE NAIL WAS ATTACHED TO TRY TO REMOVE IT, SALES REP SHOWED HIM THAT CAREFULLY BECAUSE THE BLOWS WITH THE HAMMER WERE ON THE LEGS THAT MAKE CONNECTION WITH THE BLACK GUIDE OF PROXIMAL BLOC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16854451 ↗