TRIGEN 71648238Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010501158), received between Apr 28, 2017 and Dec 20, 2022 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 20, 2022Migration or Expulsion of Device; Detachment of Device or Device Component; Migration or Expulsion of Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT A SCREW WAS PARTIALLY BACKING OUT AFTER HAVING A FRACTURE FIXATION SURGERY OF A RIGHT FEMUR FRACTURE USING THE TRIGEN TAN SYSTEM. THE PATIENT HAD MINIMAL TENDERNESS AT THE SITE. NO INTERVENTION WAS NECESSARY AND THE PATIENT ACHIEVED UNION AT 37 WEEKS AFTER THE PRIMARY PROCEDURE. 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: Extraskeletal ossification; Failure of Implant; Implant Pain

  MAUDE report 16017311 ↗
• InjuryDec 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT SUFFERED FROM TENDERNESS AND AN INFLAMMATORY REACTION OVER THE MEDIAL DISTAL SECTION OF THE FEMUR AFTER HAVING A FRACTURE FIXATION SURGERY OF THE RIGHT FEMUR USING THE TRIGEN TAN SYSTEM. THE PATIENT UNDERWENT AN UNPLANNED HARDWARE REMOVAL OF DISTAL INTERLOCKING SCREWS ON (B)(6) 2018. THE PATIENT ACHIEVED UNION AT 81 WEEKS AFTER THE PRIMARY SURGERY. 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: Inflammation; Pain

  MAUDE report 16010264 ↗
• InjuryApr 28, 2017Failure to Align; Failure to Align

  IT WAS REPORTED A SURGERY WAS DELAYED BY MORE THAN 30 MINUTES DUE TO MISALIGNMENT OF THE SCREWS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6530866 ↗

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-2444-2023 · Jul 24, 2023 · Open, Classified
  TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT, REF 71647340, Femur nail
• Z-2443-2023 · Jul 24, 2023 · Open, Classified
  TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT, REF 71647336, Femur nail