NA 04.005.548SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982086174), received between Jun 18, 2020 and Jun 18, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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.

• InjuryJun 18, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A FEMUR FRACTURE PROCEDURE USING RETROGRADE FEMORAL NAIL. DURING THE PROCEDURE, AN INCORRECT PROTECTION SLEEVE WAS USED AND THE SCREWS MISSED THE NAIL LEAVING A SMALL HOLE IN THE NAIL. THE SCREWS WERE REMOVED. THE SURGEON INSERTED THE CORRECT PROTECTION SLEEVE, DRILLED AND INSERTED SCREWS. THERE WAS A FIVE (5) MINUTE SURGICAL DELAY. THE PROCEDURE OUTCOME IS UNKNOWN. THERE WAS NO PATIENT HARM. THIS COMPLAINT INVOLVES 4 DEVICES. THIS REPORT IS FOR 1 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 58MM F/IM NAIL-STER. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Injury

  MAUDE report 10171987 ↗