NA 03.420.302Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10886982335906), received between May 8, 2025 and Sep 10, 2026 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (15 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50721075 ↗
• MalfunctionSep 10, 2026Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50721060 ↗
• MalfunctionSep 10, 2026Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50713129 ↗
• MalfunctionSep 10, 2026Material Twisted/Bent

  It was reported that there was wear and tear on the instruments and they needed to be replaced. There was no reported patient harm with no significant delay.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50713119 ↗
• MalfunctionSep 3, 2026Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50595518 ↗
• MalfunctionAug 5, 2026Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50142432 ↗
• MalfunctionAug 4, 2026Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50128627 ↗
• MalfunctionMay 8, 2026Material Twisted/Bent

  IT WAS REPORTED THAT THE SCREWDRIVER STRIPPED STAR. ANOTHER SCREWDRIVER SHAFT TIPS ARE TORQUED/DAMAGED. THE DEPTH GAUGE WON'T SLIDE. NO OPERATION INVOLVED. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25126921 ↗
• MalfunctionJan 2, 2026Break

  IT WAS REPORTED THAT SCREWDRIVER TIP BROKE OFF IN THE SCREW HEAD. BURR WAS DONE TO REMOVE THE TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23944342 ↗
• MalfunctionNov 13, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED A T6 SCREW DRIVER SHAFT STRIPPED. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23547061 ↗
• 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 22338674 ↗
• 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 22022614 ↗
• 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 22022238 ↗
• 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 22022203 ↗
• 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 22022187 ↗
• 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 22022142 ↗
• MalfunctionMay 8, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE DEVICE WAS DAMAGED DURING CASE. THE HEAD OF THE SCREWDRIVER SHAFT WARPED/BENT AFTER SCREW INSERTION BEING PUT ON POWER. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A SLIGHT SURGICAL DELAY. AN EXTRA T6 DRIVER WAS AVAILABLE TO BE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21986171 ↗