NA 04.005.550Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982086181), received between Jul 13, 2018 and Aug 14, 2019 — classified as 2 injuries.

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 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.

• InjuryAug 14, 2019Break; Break

  THIS REPORT IS AGAINST USER FACILITY MEDWATCH NUMBER MW5087929, A COPY IS ATTACHED. THE ONLY INFORMATION CONTAINED IN THIS REPORT IS CORRECTION OR ADDITIONAL INFORMATION. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT STATUS AND SURGICAL OUTCOME WERE UNKNOWN. CONCOMITANT DEVICE REPORTED: FEMORAL NAIL (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1), HELICAL BLADE (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR A LOCKING SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 8893954 ↗
• InjuryJul 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT AN EXPLANTATION PROCEDURE. TWO (2) TITANIUM LOCKING SCREWS WITH STARDRIVE FOR INTRAMEDULLARY NAILS (IM) WERE REMOVED FROM AN UNKNOWN RETROGRADE FEMORAL NAIL. THE SCREWS WERE TOO LONG AND WERE REPLACED WITH TWO SCREWS OF THE APPROPRIATE LENGTH WITHOUT INCIDENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THE PATIENT WAS STABLE FOLLOWING SURGERY. CONCOMITANT DEVICES REPORTED: RETROGRADE FEMORAL NAIL (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 60MM FOR IM NAILS. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7685488 ↗