NA 458.940Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982230850), received between Feb 27, 2020 and Apr 16, 2023 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2023, THE SURGEON REMOVED TFNA NAIL, HELICAL BLADE AND 2 DISTAL SCREWS WITH NO ISSUES. EVERYTHING WAS REMOVED SUCCESSFULLY AND NAIL WAS NOT BROKEN. THE FEMUR FRACTURED AND THE SURGEON IMPLANTED A TOTAL HIP. THIS REPORT IS FOR ONE (1)5.0 TI LOCKING SCREW 40- FOR IM NAILS THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 16748632 ↗
• InjuryFeb 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE SURGEON REMOVED A TROCHANTERIC FIXATION NAIL (TFN) BECAUSE THE PATIENT HAD ARTHRITIS. THE TFN NAIL, TITANIUM (TI) HELICAL BLADE, TITANIUM (TI) LOCKING SCREW AND END CAP WERE REMOVED WITH NO ISSUES. THERE WAS NO SURGICAL DELAY. PROCEDURE SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS IS 3 OF 4 FOR REPORT (B)(4).

  Patient problems: Arthritis; No Code Available

  MAUDE report 9762641 ↗