NA 1896-5065SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540202543), received between Mar 16, 2021 and Mar 12, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (2 reports).

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 18, 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.

• InjuryMar 12, 2025Biocompatibility; Biocompatibility

  AS PER THE LEGAL DEPARTMENT'' BGHM (BERUFSGENOSSENSCHAFT HOLZ UND METALL) INSURANCE HAVE REPORTED THAT THERE IS AN INCREASE IN LEAD, CHROMIUM, COBALT, ZINC AND CADMIUM HAS BEEN DETECTED IN THEIR INSURED¿S BLOOD AND URINE. AN ALLEGATION HAS BEEN MADE BY THE INSURED PATIENT¿S TREATING PHYSICIAN THAT THIS COMPLAINT MAY BE DUE TO THE T2 FEMORAL NAIL IMPLANTED IN THE PATIENT IN 2007."

  Patient problems: Metal Related Pathology

  MAUDE report 21588177 ↗
• InjuryJan 16, 2024Break; Fracture; Break; Fracture

  AS REPORTED BY THE CUSTOMER, "BREAKAGE OF THE DISTAL SCREWS OF THE FEMORAL NAIL".

  Patient problems: Failure of Implant

  MAUDE report 18516610 ↗
• InjuryMar 16, 2021Break; Break

  AS REPORTED: "IN (B)(6) 2018, THE PATIENT UNDERWENT OSTEOSYNTHESIS SURGERY WITH AN INTRAMEDULLARY NAIL FOR A DIAPHYSEAL FRACTURE OF THE LEFT TIBIA. SUBSEQUENTLY, THE FRACTURE EVOLVED TOWARDS A PROGRESSIVE CONSOLIDATION, WHEREBY THE FINDING OF A BREAK IN THE MOST PROXIMAL SCREW OF THE 2 DISTAL LOCKING SCREWS OF THE NAIL. DURING THE LAST OUTPATIENT CHECKS, THE PATIENT COMPLAINED OF INTOLERANCE TO THE MEANS OF SYNTHESIS, WHICH IS WHY, ON (B)(6) 2021, HE UNDERWENT COMPLETE REMOVAL OF THE NAIL AND SCREWS (DURATION OF THE PROCEDURE: 1 HOUR AND 15 MINUTES)".

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 11499244 ↗