TRIGEN 71653242Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010548467), received between May 11, 2022 and Dec 20, 2022 — 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.

• InjuryDec 20, 2022Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A BREAKAGE OF THE DISTAL INTERLOCKING SCREWS AFTER HAVING A FRACTURE FIXATION SURGERY OF THE LEFT FEMUR USING THE TRIGEN RETROGRADE FEMORAL NAIL SYSTEM. ALSO, THERE WAS WHAT APPEARS TO BE A NEW FEMORAL SHAFT FRACTURE SURROUNDING NAIL PROXIMAL TO ORIGINAL FRACTURE. THE PATIENT ACHIEVED UNION AT 27 WEEKS AFTER THE PRIMARY SURGERY. NO HARDWARE REVISION SURGERY WAS SCHEDULED. THE CURRENT STATE OF HEALTH OF THE PATIENT IS UNKNOWN. THIS INCIDENT WAS NOTICED IN A RETROSPECTIVE POST-MARKET CLINICAL FOLLOW UP ACTIVITY (PMCF) WHERE ANONYMIZED DATA SUMMARIZING OUTCOMES WERE GATHERED; THEREFORE, ADDITIONAL INFORMATION IS NOT KNOWN, AND IT IS NOT POSSIBLE TO COLLECT IT. WE DO NOT HAVE THE OPPORTUNITY TO IDENTIFY INDIVIDUAL HCPS AND REVISIT NEGATIVE FEEDBACK TO RETRIEVE FURTHER INFORMATION.

  Patient problems: Bone Fracture(s); Failure of Implant; Fall; Pain

  MAUDE report 16015553 ↗
• InjuryMay 11, 2022Break; Break

  IT WAS REPORTED THAT DURING TRAUMA SURGERY, WHILE INSERTING THE RETROGRADE NAIL, THE SURGEONS CAME UPON SOME DIFFICULTIES WITH THE PROXIMAL END OF THE NAIL; NAMELY WITH THE THREADING AND THE METAL NAIL JIG ATTACHMENT. INITIAL ENTRY WAS MADE THROUGH THE BASE OF THE KNEE WITH THE THREADED GUIDE PIN AFTER WHICH THE CANAL WAS REAMED UP TO 13MM TO FACILITATE AN 11.5MM NAIL. THE RULER WAS THEN USED TO MEASURE THE LENGTH OF THE NAIL NEEDED AND THE DECISION WAS MADE TO USE AN 11.5MM X 42MM NAIL. NEXT, THE META-NAIL ATTACHMENT WAS SECURED TO THE STERILE NAIL FOR INSERTION. UPON ENTRY INTO THE CANAL COMPLAINTS WERE MADE ABOUT THE META NAIL ATTACHMENT BECOMING LOOSE WHILE TRYING TO PASS THE NAIL WHICH ULTIMATELY RESULTED IN THE BOLT DETACHING AND FAILING OUT WHEREAFTER THE NAIL WAS ESSENTIALLY MANGLED WITH A PIECE BREAKING OFF. AFTERWARDS, INTRAOPERATIVE SCREENING REVEALED A NARROW INTRAMEDULLARY CANAL. SUBSEQUENTLY THERE WERE MAJOR DIFFICULTIES IN TRYING TO REMOVE THE DAMAGED NAIL. THE TEAM EMPLOYED THE USE OF THE HOSPITAL¿S WIRE CUTTER WHICH THEY HAVE ASKED TO BE REPLACED, A VICE GRIP, STEINMANN PINS AND LARGE NIBBLERS TO NO AVAIL. THE CHOICE WAS ULTIMATELY MADE TO RESORT TO A OSTEOTOMY TO

  Patient problems: Perforation

  MAUDE report 14364770 ↗