TRIGEN 71645134Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010541321), received between Aug 18, 2022 and Aug 18, 2022 — classified as 1 injury.

4 other recalls cover devices cleared under the same FDA submission (K040929, 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 18, 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 ADOLESCENT TAN GROUP REQUIRED A REVISION SURGERY DUE TO A SUSTAINED PERIPROSTHETIC FRACTURE, ABNORMAL PAIN AND NON-UNION OF THE FRACTURE. ADDITIONAL DETAILS REGARDING THE SPECIFIC TYPE OF FRACTURE SUSTAINED ARE YET TO BE CONFIRMED. THE PATIENT'S OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Bone Fracture(s); Discomfort; Nonunion/Delayed-union Bone Fracture

  MAUDE report 15249738 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K040929, 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