T10 DRIVER, RETAINING 5042-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00848665039320), received between May 23, 2024 and Oct 20, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (4 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.

• MalfunctionOct 20, 2025Material Twisted/Bent; Material Twisted/Bent

  ON 10/09/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT A 5042-100 T10 DRIVER TWISTED AT THE END AND STRIPPED. NO ISSUES WERE REPORTED DURING THE PROCEDURE, AND THE PATIENT WAS NOT AFFECTED. THIS WAS IDENTIFIED AFTER THE PROCEDURE, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23341242 ↗
• MalfunctionSep 30, 2024Material Twisted/Bent; Material Twisted/Bent

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06666422 THAT (B)(4)) OF A 5042-100 T10 DRIVER WAS USED WITH A TORQUE LIMITING HANDLE, YET THE THREADS WERE BENT, SO THEY DID NOT PROPERLY GRIP THE SCREWS. NO PIECES BROKE INSIDE THE PATIENT. THE CASE WAS COMPLETED SUCCESSFULLY USING A T10 DRIVER FROM THE 2.7 MINI FRAG SET WITHOUT ISSUES. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20332322 ↗
• MalfunctionSep 30, 2024Material Twisted/Bent; Material Twisted/Bent

  ON 09/18/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (QTY. 2) OF A 5042-100 T10 DRIVER WAS USED WITH A TORQUE LIMITING HANDLE, YET THE THREADS WERE BENT, SO THEY DID NOT PROPERLY GRIP THE SCREWS. NO PIECES BROKE INSIDE THE PATIENT. THE CASE WAS COMPLETED SUCCESSFULLY USING A T10 DRIVER FROM THE 2.7 MINI FRAG SET WITHOUT ISSUES. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20332198 ↗
• MalfunctionMay 23, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED ON 08/30/2022 BY A SALES REPRESENTATIVE VIA EMAIL THAT AN 5042-100 AND 5025-300 DRIVERS ARE BENT. THIS WAS DISCOVERED DURING AN UNSPECIFIED TIME WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19384301 ↗