TRIGEN 71647236Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010500816), received between Sep 12, 2022 and Dec 20, 2022 — classified as 2 injuries.

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, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT SUFFERED FROM A POSTOPERATIVE COMPLICATION OF SKIN, INVOLVING DRAINAGE FROM SURGICAL WOUND, AFTER HAVING A FRACTURE FIXATION SURGERY OF THE LEFT FEMUR USING THE TRIGEN TAN SYSTEM. THE PATIENT WAS TREATED WITH ANTIBIOTICS TO ADDRESS THE ISSUE. ALSO, THE PATIENT SUFFERED FROM WOUND ACTIVE EXTRAVASATION AND BLEEDING, AND UNDERWENT AN I&D SURGERY ON (B)(6) 2021 TO TREAT A TIGHT HEMATOMA. THE PATIENT ACHIEVED UNION 20 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: Bacterial Infection; Hematoma; Hemorrhage/Blood Loss/Bleeding; Unspecified Infection

  MAUDE report 16015849 ↗
• InjurySep 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AS PART OF A CLINICAL STUDY TITLED "ARE TAN NAILS SAFE AND EFFECTIVE FOR FEMUR FRACTURES IN ADOLESCENTS?", NINETY FIVE (95) PATIENTS UNDERWENT PRIMARY IMPLANTATION OF EITHER A TRIGEN ADOLESCENT TAN OR A TRIGEN TAN INTRAMEDULLARY NAIL TO TREAT TRAUMA FRACTURES ON THE FEMUR. FROM THIS COHORT, ONE (1) PATIENT IN THE TRIGEN TAN GROUP WHO INITIALLY UNDERWENT A ROTATIONAL OSTEOTOMY EXPERIENCED A PERIPROSTHETIC OCD FRACTURE OF THE LEFT DISTAL FEMUR 73 DAYS FOLLOWING INDEX SURGERY. THE SPECIFIC MEASURES TAKEN TO RESOLVE THIS COMPLICATION, AS WELL AS THE PATIENT'S OUTCOME REMAIN UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Bone Fracture(s)

  MAUDE report 15407815 ↗

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