TRIGEN 71653238Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010548443), received between Sep 3, 2021 and Jan 27, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (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.

• MalfunctionJan 27, 2026Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT DURING A TRAUMA SURGERY, THE INTERNAL PACKAGING OF ONE (1) META RETRO FEM NAIL 11.5 × 38 WAS FOUND TO BE DAMAGED, APPEARING RATTY AND TORN. THE OUTER BOX WAS REPORTED TO BE INTACT, AND THE HARD PLASTIC STERILIZATION SEAL WAS ALSO REPORTED AS INTACT; HOWEVER, THE PLASTIC APPEARED TORN AND PARTIALLY OPENED WHEN THE BOX WAS OPENED. STAFF CHOSE NOT TO RISK POTENTIAL CONTAMINATION OF THE PLASTIC PIECES FROM THE INTERNAL PACKAGING ENTERING THE PATIENT. THE PROCEDURE WAS COMPLETED AFTER A MINOR, NON-SIGNIFICANT DELAY USING A SIMILAR S+N BACKUP PRODUCT. NO INJURY WAS REPORTED AS A RESULT OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24196374 ↗
• InjuryDec 20, 2022Fracture; Migration or Expulsion of Device; Detachment of Device or Device Component; Fracture; Migration or Expulsion of Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT SUFFERED FROM COMPLETE BACKING OUT OF LATERAL TO MEDIAL SCREW IN NAIL, PARTIAL BACKING OUT OF MEDIAL TO LATERAL DISTAL INTERLOCKING SCREW IN NAIL, BREAKAGE OF MOST PROXIMAL OF THE DISTAL INTERLOCKING SCREWS IN NAIL, AND BREAKAGE OF DISTAL MOST SCREW IN THE NAIL AFTER HAVING A FRACTURE FIXATION SURGERY OF THE RIGHT FEMUR USING THE TRIGEN RETROGRADE FEMORAL NAIL SYSTEM. OVERALL, ALIGNMENT WAS MAINTAINED WITH CALLUS FORMATION, BUT HEALING WAS NOT COMPLETE (NONUNION). THE PATIENT ALSO SUFFERED FROM A HEMATOMA LIKELY RELATED TO PROMINENT SCREW. THE SCREW WAS REMOVED. 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: Cellulitis; Failure of Implant; Hematoma; Local Reaction; Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 16015183 ↗
• InjurySep 3, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER INTERNAL FIXATION SURGERY HAD BEEN PERFORMED ON (B)(6) 2020, THERE WAS A NON-UNION OF FEMORAL SHAFT BONE. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2021. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 12424908 ↗