NA 04.005.540SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982086099), received between Jun 12, 2018 and Sep 14, 2022 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 14, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022 SURGEON REMOVED HELICAL BLADE DUE TO BACKING OUT AND REPLACED WITH TINA SCREW. DISTAL SCREWS ALSO BROKEN. THERE WAS NO SURGERY DELAY. PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME WERE UNKNOWN. THIS REPORT IS FOR ONE (1) 5.0 TI LCKNG SCREW T25 SD 50 F/IM NAIL-S THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15422093 ↗
• InjuryJun 12, 2018Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN (B)(6) 2018, PATIENT UNDERWENT THE TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) IMPLANT PROCEDURE DUE TO A HIP FRACTURE. THREE (3) MONTHS POSTOPERATIVELY, THE DISTAL LOCKING SCREW BROKE. PATIENT¿S FRACTURE WAS HEALED. REMOVAL OF THE DEVICE HAS NOT BEEN SCHEDULED AS THEY ARE UNSURE IF THE SCREW WILL NEED REMOVAL. PATIENT STATUS WAS NOT REPORTED. CONCOMITANT DEVICE REPORTED: TFNA NAIL (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 50MM F/IM NAIL-STER. (B)(4).

  Patient problems: No Code Available

  MAUDE report 7593535 ↗