NA 04.005.575Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982086402), received between Jul 13, 2018 and Mar 26, 2019 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 26, 2019Break; Break

  UPDATE: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REVISION OF THE TIBIA DIAPHYSEAL SEGMENT. THE TITANIUM CANNULATED TIBIAL NAIL-EX WITH PROXIMAL BEND WAS REMOVED. ONE (1) TITANIUM (TI) LOCKING SCREW WITH T25 STARDRIVE RECESS 36MM, ONE (1) LOCKING SCREW WITH T25 STARDRIVE RECESS 36MM, ONE (1) LOCKING SCREW WITH T25 TI STARDRIVE RECESS 60MM, ONE (1) LOCKING SCREW WITH T25 TI STARDRIVE RECESS 44MM,ONE (1) LOCKING SCREW WITH T25 TI STARDRIVE RECESS 48MM, ONE (1) LOCKING SCREW WITH T25 TI STARDRIVE RECESS 48MM, AND ONE (1) LOCKING SCREW WITH T25 TI STARDRIVE RECESS 54MM WAS REMOVED DUE TO A NON-UNION . IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOMES WERE UNKNOWN. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 8454448 ↗
• InjuryMar 26, 2019Break; Break

  UPDATE: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REVISION OF THE TIBIA DIAPHYSEAL SEGMENT. THE TITANIUM CANNULATED TIBIAL NAIL-EX WITH PROXIMAL BEND WAS REMOVED. ONE (1) TITANIUM (TI) LOCKING SCREW WITH T25 STARDRIVE RECESS 36MM, ONE (1) LOCKING SCREW WITH T25 STARDRIVE RECESS 36MM, ONE (1) LOCKING SCREW WITH T25 TI STARDRIVE RECESS 60MM, ONE (1) LOCKING SCREW WITH T25 TI STARDRIVE RECESS 44MM,ONE (1) LOCKING SCREW WITH T25 TI STARDRIVE RECESS 48MM, ONE (1) LOCKING SCREW WITH T25 TI STARDRIVE RECESS 48MM, AND ONE (1) LOCKING SCREW WITH T25 TI STARDRIVE RECESS 54MM WAS REMOVED DUE TO A NON-UNION . IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOMES WERE UNKNOWN. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 8454447 ↗
• 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 85MM FOR IM NAILS. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7685370 ↗