T2 2339-0934SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327292459), received between Apr 18, 2023 and Apr 18, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (1 report).

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.

• InjuryApr 18, 2023Break; Fracture; Material Deformation; Material Twisted/Bent; Break; Fracture; Material Deformation; Material Twisted/Bent

  AS REPORTED: "A VOICEMAIL CAME IN TODAY FROM A T&E SALES REP FROM SAN ANTONIO, TX REGARDING THE BREAKAGE OF 3 RETROGRADE FEMUR NAILS WITHIN A 9-DAY SPAN. THE NAIL BENT AT A 50 DEGREE ANGLE WHILE THE PATIENT WAS DOING REHAB. THIS PATIENT WAS REVISED WITH SYNTHESE NAILS. PATIENT HAD GOOD BONE QUALITY. THERE WAS NON-UNION. THE PATIENT ADHERED TO ALL MOBILITY INSTRUCTIONS PROVIDED BY THE SURGEON.

  Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture

  MAUDE report 16765823 ↗