NA 04.005.552Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982086204), received between Jul 20, 2021 and Sep 16, 2022 — classified as 2 injuries, 1 malfunction.

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

• InjurySep 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THERE WAS A CONCERN OVER THE STABILITY OF FX: REMOVAL OF NAIL AND SCREWS. AN IM REAMING OF FEMORAL CANAL WAS COMPLETED. THE SURGEON PUT IN LARGER NAIL / SUPPLEMENT WITH A PROXIMAL FEMUR HOOK PLATE. THIS REPORT IS FOR ONE (1) 5.0 TI LCKNG SCR T25 SD 62 FOR IM NAILS. THIS IS REPORT 4 OF 5 FOR COMPLAINT (B)(4).

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

  MAUDE report 15438159 ↗
• MalfunctionAug 29, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SOUTH KOREA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022, THE SCREWS IN QUESTION COULD NOT BE INSERTED INTO THE BONE DURING DRILLING. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 62MM FOR IM NAILS. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15312474 ↗
• 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, PATIENT UNDERWENT A REMOVAL OF HARDWARE DUE TO INFECTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES (6) DEVICES. THIS REPORT IS FOR (1) 5.0 TI LCKNG SCR T25 SD 62 FOR IM NAILS. THIS REPORT IS 5 OF 6 FOR (B)(4).

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

  MAUDE report 12199667 ↗