NA 03.424.300Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10886982336033), received between May 14, 2025 and Sep 29, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Break; Entrapment of Device

  It was reported that the Screwdriver broke during a case and the broken fragment remained in the head of the Screw.

  Patient problems: Foreign Body In Patient

  MAUDE report 50933171 ↗
• MalfunctionAug 24, 2026Break; Crack; Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50412991 ↗
• MalfunctionAug 24, 2026Break; Crack; Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50408644 ↗
• MalfunctionAug 3, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50122602 ↗
• MalfunctionApr 29, 2026Material Twisted/Bent

  IT WAS REPORTED THAT THE VOLT SCREWDRIVER SHAFT T8 L55 HAD A STRIPPED DRIVE FEATURE, RESULTING IN THE SCREWDRIVER STRIPPING SCREW RECESSES DURING USE. THERE WAS NO REPORTED PATIENT OR USER HARM, AND NO SIGNIFICANT DELAY WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25031132 ↗
• MalfunctionJan 5, 2026Break

  IT WAS REPORTED THAT DURING TIGHTENING OF 2.4 BENDING PINS, THE NARROW TIPS OF THE T8 SCREWDRIVER BLADES (BOTH LONG AND SHORT) BROKE, RENDERING THEM UNUSABLE FOR SCREW INSERTION. THERE WAS NO REPORTED PATIENT OR USER HARM, AND NO SIGNIFICANT SURGICAL DELAY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23959673 ↗
• MalfunctionAug 28, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED ON AN UNKNOWN DATE THAT SCREWDRIVER STRIPPED AND DID NOT GRAB THE SCREW PROPERLY. NO FRAGMENTS WERE GENERATED. THERE WAS NO SURGICAL DELAY DUE TO THE REPORTED EVENT AND PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22917382 ↗
• MalfunctionJun 26, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THE SCREWDRIVER TIPS WERE WORN OUT AND NO LONGER WORKING PROPERLY. A SCREW HEAD WAS STRIPPED AND HAD TO BE REMOVED CAUSING A MINIMAL DELAY IN SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22340189 ↗
• MalfunctionMay 14, 2025Calibration Problem; Material Twisted/Bent; Calibration Problem; Material Twisted/Bent

  IT WAS REPORTED THAT SCREWDRIVERS WERE PUT ON HAND WITH TOO MUCH TORQUE AND WERE STRIPPED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22022343 ↗
• MalfunctionMay 14, 2025Calibration Problem; Material Twisted/Bent; Calibration Problem; Material Twisted/Bent

  IT WAS REPORTED THAT SCREWDRIVERS WERE PUT ON HAND WITH TOO MUCH TORQUE AND WERE STRIPPED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22022305 ↗