NA 04.005.544Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982086129), received between Mar 26, 2019 and Aug 12, 2021 — classified as 4 injuries.

The most frequently reported specific device problem is “Break” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT UNDERWENT A PROCEDURE DUE TO AN INFECTION OF A LEFT TIBIAL FRACTURE. INITIALLY, THE ORIGINAL DATE OF THE SURGERY WAS ON (B)(6) 2021. POST OP EVALUATION WAS AN INFECTION, DECISION WAS MADE TO REMOVED HARDWARE. ALL ITEMS WERE INTACT THERE WERE NO FRAGMENTS, NO BROKEN PIECES. PATIENT HAS TURN SURGERY WELL AND WAS DOING FINE POSTOPERATIVELY. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS FOR (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 34MM FOR IM NAILS. THIS REPORT IS 3 OF 6 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12316177 ↗
• 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 8454455 ↗
• 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 8454452 ↗
• 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 8454449 ↗