NA 458.938Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982230836), received between Jun 25, 2020 and Aug 13, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Twisted/Bent” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT A SCREW WAS RECEIVED FOR INVESTIGATION WITHOUT AN ASSOCIATED ALLEGATION. UPON VISUAL INSPECTION, IT WAS DETERMINED THAT THE DEVICE WAS STRIPPED. THIS REPORT IS FOR A 5.0MM TITANIUM (TI) LOCKING SCREW 38MM- FOR IM NAILS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12318144 ↗
• InjuryJun 25, 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 ALL THREE TROCHANTERIC FIXATION NAIL (TFN) TO THE PATIENT NOT HEALING AND NEEDING TO CONVERT TO A TOTAL HIP. THERE WAS NO SURGICAL DELAY REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: 10MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE (PART NUMBER 456.315S, LOT H053179, QUANTITY 1), 11.0MM TI HELICAL BLADE 95MM (PART NUMBER 456.304, LOT 3L39728, QUANTITY 1). THIS REPORT INVOLVES ONE (1) 5.0MM TI LOCKING SCREW 38MM- FOR IM NAILS. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 10194922 ↗