NA 03.045.005Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10886982292520), received between Oct 12, 2021 and Sep 22, 2026 — classified as 30 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (16 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 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Device-Device Incompatibility; Material Twisted/Bent

  It was reported that the screwdriver was being used to put in a distal screw in the TFNA in the patient. The bone was very hard. Screwdriver and retention pin twisted and will not come apart. Patient was not harmed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50857101 ↗
• MalfunctionFeb 23, 2026Material Deformation

  IT WAS REPORTED ON AN UNKNOWN DATE, THAT ONE INSTRUMENT WAS BENT AND THE OTHER WILL NOT STAY INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24412780 ↗
• MalfunctionNov 25, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025 THE ANS POWER DRIVER 03.045.005 WAS CONSIDERED DEFECTIVE AS IT DID NOT ATTACH TO T HANDLE. ALL OTHER DEVICES CONNECTED TO THE T HANDLE, SO IT HAS BEEN VERIFIED THAT IT IS THE POWER DRIVER THAT IS DEFECTIVE. DIFFERENT SCREWDRIVER WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23643185 ↗
• MalfunctionNov 14, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2025, ITEMS WERE WORN AND WARPED / BROKEN RETENTION PIN AND NEED TO BE REPLACED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23556821 ↗
• MalfunctionNov 14, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THE RETENTION PINS OF THE INSTRUMENTS WERE WARPED/BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23555598 ↗
• MalfunctionNov 14, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THE RETENTION PINS OF THE INSTRUMENTS WERE WARPED/BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23555594 ↗
• MalfunctionNov 14, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THE RETENTION PINS OF THE INSTRUMENTS WERE WARPED/BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23555593 ↗
• MalfunctionNov 14, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THE RETENTION PINS OF THE INSTRUMENTS WERE WARPED/BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23555576 ↗
• MalfunctionSep 18, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON AN UNKNOWN DATE THAT MULTIPLE SCREWDRIVERS WERE NOT SECURING ONTO SCREWS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23089910 ↗
• MalfunctionSep 18, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON AN UNKNOWN DATE THAT MULTIPLE SCREWDRIVERS WERE NOT SECURING ONTO SCREWS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23089771 ↗
• MalfunctionSep 18, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON AN UNKNOWN DATE THAT MULTIPLE SCREWDRIVERS WERE NOT SECURING ONTO SCREWS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23089770 ↗
• MalfunctionSep 18, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON AN UNKNOWN DATE THAT MULTIPLE SCREWDRIVERS WERE NOT SECURING ONTO SCREWS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23089757 ↗
• MalfunctionSep 4, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT THE RETENTION PIN SNAPPED AT THE TIP WHILST DOING THE FINAL TIGHTENING OF THE DISTAL SCREWS IN A ANS TIBIA NAIL. STAFF BELIEVE THAT THEY MAY HAVE CROSSED THREADED THE RETENTION PIN INTO SCREW RECESS WHEN DOING FINAL TIGHTENING OF SCREWS. PATIENT WAS YOUNG AND FIT WITH GOOD BONE QUALITY. SURGERY WAS NOT DELAYED AND THE REMAINING SCREWS WERE INSERTED WITHOUT THE RETENTION PIN. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22964658 ↗
• MalfunctionSep 4, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE SCREWDRIVER IS WARPED AND WOULDN¿T ENGAGE WITH THE SCREW HEAD PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22963089 ↗
• MalfunctionAug 8, 2025Break; Break

  IT WAS REPORTED THAT THE SCREWDRIVER SPRING WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22754923 ↗
• MalfunctionAug 4, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH THE SCREWDRIVER SHAFT. THE SCREWDRIVER SHAFT WAS USED ON A SURGERY USING TNA, AND THE SURGEON TRIED TO USE A LOCKING SCREW (5MM) BUT COULDN¿T. WHEN THEY CHECKED THE TIP OF THE SCREWDRIVER SHAFT, IT WAS FOUND THAT THE THREADED PART WAS BROKEN. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22702016 ↗
• MalfunctionJul 24, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE END OF THE POWER WAS SHORTEN AND STRIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22592731 ↗
• MalfunctionJul 18, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN (B)(6) 2025, THE RETENTION PIN OF THE ANS SCREWDRIVER WOULD NOT CLICK IN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22545896 ↗
• MalfunctionJun 27, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE WAS ALLEGATION AGAINST THE TIBIAL NAIL - THE POLYMER JAMMED IN NAIL WHEN BACKING IT OUT. 8MM BROKE OFF POSTERIOR CORTEX. DRIVERS ARE WARPED FROM USAGE. TNA DRIVE CAP PIN IS FALLING OUT FROM HAMMERING. THE PATIENT DID NOT EXPERIENCED ANY ADVERSE EVENT. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22345621 ↗
• MalfunctionJun 27, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THERE WAS ALLEGATION AGAINST THE TIBIAL NAIL, POLYMER JAMMED IN NAIL WHEN BACKING IT OUT. THE 8MM BROKE OFF POSTERIOR CORTEX. THE DRIVERS ARE WARPED FROM USAGE. TNA DRIVE CAP PIN IS FALLING OUT FROM HAMMERING. THE PATIENT DID NOT EXPERIENCED ANY ADVERSE EVENT. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22344854 ↗
• MalfunctionMay 21, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2025, WHEN INSERTING A 5.0 LOCKING SCREW INTO THE DISTAL HOLE OF THE 170MM TFNA, THE XL25 POWER SCREWDRIVER SHAFT AND RETENTION PIN SNAPPED OFF. THE TIP OF THE SCREWDRIVER POWER SHAFT AND THE THREADS OF THE RETENTION PIN WERE STUCK IN THE HEAD OF THE SCREWDRIVER. THIS KEPT THE SURGEON FROM BEING ABLE TO ADVANCE THE SCREW OR TAKE IT OUT. NO SCREWDRIVER WAS ABLE TO GRAB THE HEAD OF THE SCREW. THIS LEFT THE SCREW PROTRUDING. SURGEON TRIED TO USE ANOTHER SCREWDRIVER TO REMOVE THE SCREW BUT THE HEAD WAS TAKEN UP BY THE SCREW DRIVER PIECES INSIDE IT. SURGERY WAS DELAYED BY 15 MINUTES DUE TO THE REPORTED EVENT. PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE PATIENT CONSEQUENCES AS THE PROTRUDING SCREW HEAD MAY CAUSE SOFT TISSUE IRRITATION POST-OP.

  Patient problems: Foreign Body In Patient

  MAUDE report 22063145 ↗
• MalfunctionDec 12, 2024Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED STATES THAT IT CAN NOT BE ASSEMBLED WITHOUT EXTREME FORCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20917154 ↗
• MalfunctionDec 12, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024 THE SCREWDRIVER WOULD NOT ALLOW RETENTION PIN TO BE INSERTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20916856 ↗
• MalfunctionOct 14, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SCREWDRIVER WAS USED IN THE CASE AND APPEARED TO BE WOBBLY IN THE CONNECTION. IT SEEMED TO NOT BE DRIVING STRAIGHT. THE PATIENT WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20441262 ↗
• MalfunctionOct 2, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE END OF THE SCREWDRIVER IS ROTATED AND WILL NOT ALLOW THE SCREW TO CAPTURE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME WAS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE SCRDRIVER SFT/RETAINING QC HEX 12/ XL25.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20352767 ↗