NA 03.045.001Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10886982292483), received between Mar 8, 2022 and Sep 18, 2025 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (7 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• 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 23089768 ↗
• 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 22345653 ↗
• 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 22345625 ↗
• 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 22345623 ↗
• 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 22345030 ↗
• MalfunctionApr 23, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING A PROCEDURE, A SCREWDRIVER WAS DEFECTIVE; INSERTION OF CAP RETENTION PIN INSTEAD OF SCREW RETENTION PIN DIAM. 5 ON XL25 SCREWDRIVER. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21894510 ↗
• MalfunctionMar 24, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2025 THE THREADS INSIDE HANDLE STRIPPED. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21676297 ↗
• MalfunctionJan 2, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PERIOSTEAL ELEVATOR 6MM CURVED BLADE DRIVER COLLET SNAPPED, RESULTING IN LOOSE CONNECTION (X2), WILL NO LONGER HOLD DRIVERS. THE UNIVERSAL SCREWDRIVER HANDLE TIPS (X2) HAVE CHIPPED AND SHARPENED. THESE ARE UNABLE TO BE USED. THE SCREW DRIVER/CANNULATED/XL25 DRIVER AND RETENTION PIN BECAME BOUND, AND PIN IS UNABLE TO BE REMOVED. THERE WAS NO OPERATION OR PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21057575 ↗
• MalfunctionJul 19, 2024Break; Crack; Contamination /Decontamination Problem; Device-Device Incompatibility; Break; Crack; Contamination /Decontamination Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DEVICES WERE CHIPPING AND CRACKING AND WAS UNABLE TO STERILIZE OR ASSEMBLE, THEREFORE IT WAS UNABLE TO BE USE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SCREW DRIVER/CANNULATED/XL25. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19784603 ↗
• MalfunctionApr 22, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SCREWDRIVER WAS JAMMED WITHIN THE CANNULATION. IT DID NOT ALLOW THE RETENTION PIN TO BE INSERTED NORMALLY AND WOULD NOT ALLOW THE USE OF THE SELF-RETAINING FEATURE. THE PIN WAS GETTING BLOCKED BEFORE FALLING INTO THE SCREWDRIVER AND THE CANNULATION FEELS TOO NARROW FOR THE PIN. SURGEON TIED TO CLEAR THE PIN WITH A BRUSH BUT NOTHING WAS WORKING. ONLY ONE OUT OF THE 4 SEEMED TO BE FAULTY. THERE WAS NO PATIENT INVOLVEMENT. THE ISSUE WAS DISCOVERED BEFORE IT COULD USE IN A CASE. THIS REPORT IS FOR ONE (1) SCREWDRIVER XL25 THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19155208 ↗
• MalfunctionOct 10, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED ON UNKNOWN EVENT DATE THAT THE RETENTION PIN DOES NOT THREAD INTO THE DRIVER. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. PATIENT CONSEQUENCE IS UNKNOWN. THIS REPORT IS FOR ONE (1) SCREW DRIVER/CANNULATED/XL25 THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17908713 ↗
• MalfunctionSep 6, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM AUSTRALIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING LOAN KIT INSPECTION ON AUGUST 2, 2023, A SCREWDRIVER XL25 AND RETENTION PIN XL40 WERE STUCK TOGETHER. THIS REPORT IS FOR A SCREWDRIVER XL25. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17693475 ↗
• MalfunctionJul 14, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE AND MONTH IN 2023, SALES REPRESENTATIVE HAVE SOME ITEMS THAT NEED TO BE WARRANTED BECAUSE OF DAMAGES IN OCCURRED IN STERILE PROCESSING DEPARTMENT. NONE OF THESE HAD ANY PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SCREWDRIVER XL25. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17329629 ↗
• MalfunctionSep 20, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE SALES CONSULTANT HAS A RETENTION PIN IS STUCK INSIDE A SCREWDRIVER. THERE WAS NO PATIENT INVOLVEMENT. CONCOMITANT PRODUCT: SCREW DRIVER/CANNULATED/XL25 (PART #03.045.001, LOT #UNK, QUANTITY #1). THIS REPORT IS FOR ONE (1)SCRDRIVER XL25. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15459177 ↗
• MalfunctionSep 1, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, WHEN INSERTING DISTAL INTERLOCKS INTO A TNA, THE XL25 SCREWDRIVER AND COUPLING SCREW WOULD NOT FULLY ENGAGE AND RETAIN AN XL25 RECESS LOCKING SCREW. ANOTHER SCREWDRIVER WAS OPENED AND THE SCREW WAS INSERTED WITHOUT DELAY. THE PROCEDURE OUTCOME IS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE SCREWDRIVER XL25. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15335102 ↗
• MalfunctionJul 11, 2022Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE A SCREWDRIVER BROKE. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) SCREWDRIVER XL25. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14978212 ↗
• MalfunctionMar 8, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING POST-OPERATIVE INSPECTION, THE CABLE PASSER WAS BENT, AWLS WERE BENT, AND THE SCREWDRIVERS HEADS WERE STRIPPED AFTER HIGH VOLUME USAGE. THE GRAPHIC CASES BLACK SIDES WERE TEARING OFF. NO PATIENT INVOLVEMENT REPORTED. THIS REPORT IS FOR ONE (1) SCREWDRIVER XL25. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13693209 ↗
• MalfunctionMar 8, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING POST-OPERATIVE INSPECTION, THE CABLE PASSER WAS BENT, AWLS WERE BENT, AND THE SCREWDRIVERS HEADS WERE STRIPPED AFTER HIGH VOLUME USAGE. THE GRAPHIC CASES BLACK SIDES WERE TEARING OFF. NO PATIENT INVOLVEMENT REPORTED. THIS REPORT IS FOR ONE (1) SCREWDRIVER XL25. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13692996 ↗