TRIGEN 71647340Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010500946), received between Jun 1, 2021 and Dec 20, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K040462, K210980); they may or may not involve this specific model.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT SUFFERED FROM PAIN AND NON-UNION AFTER HAVING A FRACTURE FIXATION SURGERY OF A LEFT PATHOLOGICAL FEMUR FRACTURE USING THE TRIGEN TAN SYSTEM. THE PATIENT HAD A BROKEN SCREW AND A SCREW BACKING OUT. THE PATIENT UNDERWENT A REVISION SURGERY TO ADDRESS THE ISSUE. THE PATIENT DID NOT ACHIEVE UNION. 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: Cancer; Failure of Implant; Inadequate Osseointegration; Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 16017089 ↗
• InjuryJun 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A NAIL SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PAIN AT THE SCREW SITES (PART AND LOT NUMBER WILL NOT BE AVAILABLE). THE ISSUE WAS ADDRESSED VIA REMOVAL OF 11.5 X 40 130 D TAN LT LIME IN A REVISION SURGERY ON (B)(6) 2021. THE REMOVAL WAS QUICK AND WITHOUT INCIDENT. IT IS UNKNOWN IF THERE WAS A REPLACEMENT OF INSTRUMENT.

  Patient problems: Pain

  MAUDE report 11912857 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K040462, K210980. One submission often covers many models, so check the product and lot details in each record.

• Z-2456-2026 · Mar 16, 2026 · Open, Classified
  TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816
• Z-1806-2025 · Mar 18, 2025 · Open, Classified
  META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690
• Z-2443-2023 · Jul 24, 2023 · Open, Classified
  TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT, REF 71647336, Femur nail
• Z-2444-2023 · Jul 24, 2023 · Open, Classified
  TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT, REF 71647340, Femur nail