NA 03.010.109Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10886982067814), received between Dec 5, 2018 and Feb 4, 2026 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (13 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 4, 2026Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE PRODUCT IS BENT AND CANNOT GO INTO THE DRILL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24258836 ↗
• MalfunctionApr 24, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE WAS BURRING ON THE DRIVER TIP. THIS WAS IDENTIFIED DURING LOAN KIT INSPECTION BY THE LOAN KIT TECHNICIAN. THE EVENT DATE IS THE DATE THE INSPECTION TOOK PLACE. THERE ARE NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21898512 ↗
• MalfunctionFeb 13, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OP INSPECTION REVEALED THAT SEVERAL SCREWDRIVERS WERE STRIPPED AND NEEDED REPLACEMENT. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21378640 ↗
• MalfunctionJan 28, 2025Material Discolored; Material Twisted/Bent; Material Discolored; Material Twisted/Bent

  IT WAS REPORTED THAT DURING POST OP INSPECTION, ITEMS WERE STRIPPED AND DISCOLORED FROM WASH OF CENTRAL STERILE PROCESSING DEPARTMENT (CSPD). THERE WAS NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21252642 ↗
• MalfunctionJan 28, 2025Material Discolored; Material Twisted/Bent; Material Discolored; Material Twisted/Bent

  IT WAS REPORTED THAT DURING POST OP INSPECTION, ITEMS WERE STRIPPED AND DISCOLORED FROM WASH OF CENTRAL STERILE PROCESSING DEPARTMENT (CSPD). THERE WAS NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21252639 ↗
• MalfunctionJan 27, 2025Material Discolored; Material Twisted/Bent; Material Discolored; Material Twisted/Bent

  IT WAS REPORTED THAT DURING POST OP INSPECTION, ITEMS WERE STRIPPED AND DISCOLORED FROM WASH OF CSPD. THERE WAS NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21245383 ↗
• MalfunctionOct 23, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT WHILE INSPECTING INSTRUMENTS AFTER GOING THROUGH THE DECONTAMINATION PROCESS, THE SALES REPRESENTATIVE NOTICED THAT SEVERAL WERE DAMAGED. IT IS UNKNOWN WHEN THE INSTRUMENTS WERE DAMAGED. THERE WAS NO REPORTED PATIENT INVOLVEMENT. THE AFFECTED PRODUCTS ARE: 1. DISTRACTOR: THERE IS A SPRING TECH DEVICE IN THE HANDLE, AND THAT SPRING DEVICE IS BROKEN. 2. DEPTH GAUGE: BENT AND UNABLE TO BE USED. 3. POWER ADAPTER FOR SCHANTZ PINS: STRIPPED AND UNABLE TO HOLD THE PIN IN IT. 4. TENSION HOLDER FOR THE CABLE SET (3X): WILL NOT HOLD THE ATTACHMENT BIT FOR THE TENSION HOLDER ANY LONGER. 5. ATTACHMENT BIT (3X): THE TIPS OF THESE WERE BENT IN; THE CABLE WAS UNABLE TO GO THROUGH IT. 6. HANDLE QUICK COUPLING (2X): THE RUBBER ON THE HANDLE WAS CUT AND NOT ALLOWING THE HANDLE TO BE CLEANED PROPERLY. 7. T25 SCREWDRIVER (2X): THE TIP WAS STRIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20514046 ↗
• MalfunctionOct 23, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT WHILE INSPECTING INSTRUMENTS AFTER GOING THROUGH THE DECONTAMINATION PROCESS, THE SALES REPRESENTATIVE NOTICED THAT SEVERAL WERE DAMAGED. IT IS UNKNOWN WHEN THE INSTRUMENTS WERE DAMAGED. THERE WAS NO REPORTED PATIENT INVOLVEMENT. THE AFFECTED PRODUCTS ARE: 1. DISTRACTOR: THERE IS A SPRING TECH DEVICE IN THE HANDLE, AND THAT SPRING DEVICE IS BROKEN. 2. DEPTH GAUGE: BENT AND UNABLE TO BE USED. 3. POWER ADAPTER FOR SCHANTZ PINS: STRIPPED AND UNABLE TO HOLD THE PIN IN IT. 4. TENSION HOLDER FOR THE CABLE SET (3X): WILL NOT HOLD THE ATTACHMENT BIT FOR THE TENSION HOLDER ANY LONGER. 5. ATTACHMENT BIT (3X): THE TIPS OF THESE WERE BENT IN; THE CABLE WAS UNABLE TO GO THROUGH IT. 6. HANDLE QUICK COUPLING (2X): THE RUBBER ON THE HANDLE WAS CUT AND NOT ALLOWING THE HANDLE TO BE CLEANED PROPERLY. 7. T25 SCREWDRIVER (2X): THE TIP WAS STRIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20513876 ↗
• MalfunctionSep 6, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2024, THE T25 WAS STRIPPED IN CASE AND DISCARDED BY STAFF. IT WAS UNKNOWN IF THERE WERE ANY PATIENT STATUS/ OUTCOME / CONSEQUENCES.

  Patient problems: Insufficient Information

  MAUDE report 20162457 ↗
• MalfunctionSep 6, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AUG 17, 2024, THE T25 WAS STRIPPED IN CASE AND DISCARDED BY STAFF. IT WAS UNKNOWN IF THERE WERE ANY PATIENT STATUS/ OUTCOME / CONSEQUENCES.

  Patient problems: Insufficient Information

  MAUDE report 20162423 ↗
• MalfunctionSep 6, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AUG 17, 2024, THE T25 WAS STRIPPED IN CASE AND DISCARDED BY STAFF. IT WAS UNKNOWN IF THERE WERE ANY PATIENT STATUS/ OUTCOME / CONSEQUENCES.

  Patient problems: Insufficient Information

  MAUDE report 20161766 ↗
• MalfunctionMar 18, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2024 THE TIP OF DRIVER SHAFT WAS WORN OUT. THERE WAS NO OPERATION INVOLVED. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE SCRDRIVER T25 L280 F/QC. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18921780 ↗
• MalfunctionApr 19, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A SHORT TFNA PROCEDURE WITH 125 DEGREE AIMING ARM, THE DRILL BIT HIT THE NAIL¿S DISTAL INTERLOCKS. THERE WAS DIFFICULTY INSERTING THE SCREW WITH THE LONG T25 POWER. WITH PERFECT CIRCLE TECHNIQUE THE SCREW WAS INSERTED. A MALLET WAS USED TO TAP ON THE DRIVER AND THE SCREWDRIVER HEAD SEEMED STRIPPED. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT OUTCOME. THIS REPORT INVOLVES ONE (1) STARDRIVE SCREWDRIVER SHAFT T25/SELF-RETAINING QC 280MM. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16769072 ↗
• MalfunctionOct 25, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, WHILE CONNECTING THE T25 POWER SCREWDRIVER SHAFT TO THE QUICK CONNECT, AND IT WAS REALIZED THAT SLIGHTLY BENT AND NOT CONNECTING PROPERLY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. NO FRAGMENTS WERE GENERATED. THERE WAS NO PATIENT OUTCOME/CONSEQUENCES. THIS REPORT IS FOR ONE (1) SD SCRDRIVER SFT T25/SELF-RETAIN QC 280. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15666615 ↗
• MalfunctionDec 5, 2018Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2018, DURING A HARDWARE REMOVAL, THE UNKNOWN SCREWDRIVER BROKE WHILE REMOVING A SCREW. ANOTHER UNKNOWN SCREWDRIVER WAS USED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS STABLE. CONCOMITANT DEVICES REPORTED: UNKNOWN SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS COMPLAINT INVOLVES 1 (ONE) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8135763 ↗