NA 04.005.522Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982085900), received between Jun 25, 2021 and Apr 15, 2022 — classified as 5 injuries.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS REMOVAL OF TIBIAL NAIL DUE TO INFECTION. THERE WAS NO SURGERY DELAYED DUE TO THE REPORTED EVENT. PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED.

  Patient problems: Unspecified Infection

  MAUDE report 14119450 ↗
• InjuryFeb 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, PATIENT UNDERWENT A REMOVAL OF NAIL DUE TO NONUNION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 32MM FOR IM NAILS. THIS IS REPORT 6 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 13560199 ↗
• InjuryFeb 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, PATIENT UNDERWENT A REMOVAL OF HARDWARE DUE TO PAIN. THERE WAS NO MALFUNCTION IN HARDWARE NOTED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. THIS REPORT INVOLVES ONE (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 32MM FOR IM NAILS. THIS IS REPORT 2 OF 5 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 13451191 ↗
• InjuryJul 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT REVISION SURGERY BECAUSE WHILE AT A FACILITY WHILE TRANSFERRING BEDS, THE PATIENT WAS DROPPED, RESULTING IN ANOTHER FRACTURE. 11MM/130 DEG TI CANN PROXIMAL FEMORAL NAILING SYSTEM (TFNA), TFNA FENESTRATED SCREW, AND 5.0MM TI LOCKING SCREW WERE REMOVED. THEY WERE NOT BROKEN; THEY WERE IN PLACE. THE TFNA WAS REMOVED AND EXCHANGED FOR A LONGER NAIL. THERE WAS NO INFECTION OR BROKEN IMPLANTS. THE PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS COMPLAINT INVOLVES (3) DEVICES. THIS REPORT IS FOR (1) 5.0 TI LCKNG SCR T25 SD 32 FOR IM NAILS. THIS REPORT IS 3 OF 3 FOR (B)(4).

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

  MAUDE report 12198838 ↗
• InjuryJun 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT HARDWARE REMOVAL DUE TO PAIN. TROCHANTERIC FEMORAL NAILING ADVANCED (TFNA) SCREW, TROCHANTERIC FEMORAL NAILING ADVANCED (TFNA) FEMORAL NAIL AND TITANIUM LOCKING SCREW WERE REMOVED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS COMPLAINT INVOLVE (3) DEVICES. THIS REPORT IS FOR (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 32MM FOR IM NAILS. THIS REPORT IS 3 OF 3 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 12071403 ↗