NA SD03.120.017Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982262172), received between Aug 9, 2018 and Aug 10, 2026 — classified as 4 malfunctions.

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 16, 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.

• MalfunctionAug 10, 2026Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50198956 ↗
• MalfunctionDec 26, 2025Break; Break

  IT WAS REPORTED THE SCREWDRIVER BROKE WHILE INSERTING THE TFNA LAG SCREW. NO FRAGMENTS WERE GENERATED. THE SCREW WAS ABLE TO BE INSERTED BY HAND INSTEAD OF POWER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAY OR PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23898317 ↗
• MalfunctionJan 29, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE POWER INSERTER STRIPPED. IT WAS UNKNOWN HOW THE ISSUE WAS DISCOVERED. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) T-HANDLE DRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11251476 ↗
• MalfunctionAug 9, 2018Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE T-HANDLE DRIVER WAS FOUND BROKEN AFTER IT CAME OUT OF THE WASH. THERE IS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A T-HANDLE DRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7768280 ↗