NA 03.111.038Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10886982072368), received between Mar 6, 2017 and Feb 3, 2026 — classified as 25 malfunctions.

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

• MalfunctionFeb 3, 2026Break

  THE HANDLE WAS NOTED TO BE DAMAGED PRIOR TO SURGERY. THE SPRING WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24251534 ↗
• MalfunctionAug 7, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED A AO QUICK COUPLING SCREWDRIVER HANDLE DOESN'T HOLD DRIVER BITS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22741322 ↗
• MalfunctionJul 2, 2025Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED THAT THE HANDLE WITH QUICK COUPLING HAS THE LOCKING PIN WHICH IS STUCK IN THE EXTENDED POSITION AND CANNOT BE DEPRESSED, RENDERING THE INSTRUMENT NON-FUNCTIONAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22384825 ↗
• MalfunctionJun 25, 2025Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2025. THE SCREWDRIVER HANDLE BROKE DURING THE PROCEDURE. A NEW SCREWDRIVER HANDLE WAS OPENED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A TWO MINUTE DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22331202 ↗
• MalfunctionMay 28, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE QUICK COUPLE WAS NOT LATCHING OR HOLDING DRILL BIT OR SCREW DRIVERS. THE PRODUCT DAMAGE HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION BY THE LOAN KIT TECHNICIAN. THERE ARE NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22097234 ↗
• MalfunctionSep 17, 2024Break; Break

  IT WAS REPORTED THAT ON SEP 4, 2024, BACK OF DRIVER FELL OFF AND IS NO LONGER FUNCTIONAL. THERE WAS NO SURGICAL DELAY. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20235774 ↗
• MalfunctionMar 1, 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 IN QUESTION WERE UNABLE TO STERILIZE AND COULD NOT BE ASSEMBLED. CHIPPING AND CRACKING WAS OBSERVED, THE PRODUCTS ARE UNABLE TO BE OBSERVED. THERE WAS NO REPORTED PATIENT OR PROCEDURE INTERACTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A HANDLE WITH QUICK COUPLING. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18815484 ↗
• MalfunctionFeb 29, 2024Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED THAT ON FEBRUARY 13, 2024, THE SCREWDRIVER HANDLE (03.111.038) WAS GIVEN BY THE INSTRUMENT COORDINATOR. THE SILVER CAP CAME OFF THE BACK OF THE HANDLE, AND A BEARING SEEMS TO BE MISSING. UNKNOWN WHEN EVENT OCCURRED. WAS DISCOVERED BROKEN BY SPD. THIS REPORT IS FOR ONE (1) HANDLE WITH QUICK COUPLING THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18806442 ↗
• MalfunctionJan 25, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON JANUARY 10 2024, DURING ROUTINE MEDICAL DEVICE REPROCESSING, MEDICAL DEVICE REPROCESSING STAFF IDENTIFIED THAT THE SPRING-LOADED RETAINING TIP OF COMPLAINED ITEM HAD BECOME DISENGAGED FROM THE BODY OF THE INSTRUMENT. THIS DISENGAGEMENT RENDERED THE INSTRUMENT NO LONGER FUNCTIONAL. AS A RESULT, THE COMPLAINED ITEM WAS SUBSEQUENTLY DISCARDED. A REPLACEMENT IS REQUIRED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) HANDLE WITH QUICK COUPLING THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18580427 ↗
• MalfunctionDec 6, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT ON NOVEMBER 16, 2023, THE END OF THE SCREWDRIVER HANDLE FOR THE VARIABLE ANGLE (VA) MIDFOOT FOREFOOT SET FELL OFF IN THE WASH IN STERILE PROCESSING. THE METAL TABS THAT CONNECT THE END OF THE HANDLE TO THE MAIN PORTION OF THE SCREWDRIVER WERE EXPOSED. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A HANDLE WITH QUICK COUPLING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18278580 ↗
• MalfunctionJul 10, 2023Break; Break

  IT WAS REPORTED ON AN UNKNOWN DATE, THE HANDLE CAP WAS BROKEN. THIS REPORT IS FOR HANDLE WITH QUICK COUPLING FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17287767 ↗
• MalfunctionMay 15, 2023Break; Break

  IT WAS REPORTED THAT ON APRIL 28, 2023 THE SCREWDRIVER HANDLE WAS FOUND IN SPD WITH A BROKEN TAG ON IT. THE SILVER CAP WAS POPPING OFF, AND THE METAL PEGS IN THE BLUE HANDLE PORTION HAVE BACKED OUT. THIS CREATES A POINT IN THE HANDLE IN WHICH SURGEONS GLOVES CAN TEAR AND CREATE CONTAMINATION. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) HANDLE WITH QUICK COUPLING. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16934346 ↗
• MalfunctionApr 17, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023, DURING THE FINAL TIGHTENING A SCREW WITH THE BLUE HANDLE SCREW DRIVER BROKE IN HALF AND HAD TO USE ANOTHER SCREWDRIVER. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) HANDLE WITH QUICK COUPLING. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16751947 ↗
• MalfunctionNov 1, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022 THE HANDLE BROKE DUE TO UNKNOWN REASON. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT IS FOR ONE (1) HANDLE WITH QUICK COUPLING. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15708398 ↗
• MalfunctionAug 29, 2022Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT THE SPRING IS BROKEN IN SCREWDRIVER AND IS NO LONGER FUNCTIONAL. THIS REPORT IS FOR ONE (1) HANDLE WITH QUICK COUPLING. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15315624 ↗
• MalfunctionMay 26, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED BY THE SALES REP IN CANADA THAT DURING ROUTINE PROCESSING, IT WAS OBSERVED THAT THE THE METALLIC ROTATING END PIECE ON THE QUICK COUPLING DEVICE HAD BECOME PERMANENTLY DISENGAGED AND WOULD NO LONGER STAY ATTACHED TO THE REST OF THE SHAFT. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS COMPLAINT INVOLVES ONE(1) DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14517326 ↗
• MalfunctionMay 25, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A STANDARD SURGICAL PROCEDURE, NURSING STAFF NOTED THAT THE QUICK COUPLING TIP OF COMPLAINED ITEM 03.111.038 HAD FAILED AND WAS NO LONGER ABLE TO ENGAGE AND LOCK THE T8 STARDRIVE SCREWDRIVER SHAFT IN PLACE. AN ALTERNATIVE SCREWDRIVER HANDLE FROM THE SET WAS UTILIZED AND THE SURGERY FINISHED SUCCESSFULLY WITHOUT ANY DELAY. ITEM 03.111.038 WAS DEEMED TO BE NO LONGER FUNCTIONAL AND IT WAS SUBSEQUENTLY DISCARDED. A REPLACEMENT IS REQUIRED. CONCOMITANT DEVICE REPORTED: UNK - SCREWDRIVERS: SHAFTS (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1) THIS COMPLAINT INVOLVES ONE(1) DEVICE HANDLE WITH QUICK COUPLING. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14498346 ↗
• MalfunctionFeb 25, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2021, IT WAS FOUND THAT THE SCREWDRIVER SHAFTS WERE NOT GETTING COUPLING INTO THE QUICK COUPLING ATTACHMENT AND KEPT FALLING OUT. THERE WAS NO SURGICAL DELAY. NO FURTHER INFORMATION PROVIDED. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWDRIVER SHAFTS (PART # UNKNOWN; LOT# UNKNOWN; QUANTITY:1). THIS REPORT IS FOR ONE (1) HANDLE WITH QUICK COUPLING. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11382049 ↗
• MalfunctionJan 12, 2021Break; Break

  IT WAS REPORTED THAT DURING A ROUTINE INSPECTION ON (B)(6) 2020, SEVERAL ISSUES WERE NOTED. THE MULTI HOLE WIRE GUIDE TIP HAS BEEN DAMAGED; GUIDE WIRES CANNOT GO THROUGH. THE RATCHETING SCREWDRIVER HANDLE IS CHIPPED. THE FLEXIBLE SHAFT CONNECTOR FOR USE WITH JACOBS CHUCK IS MISSING THE INTERNAL PART THAT LOCKS IN SHAFT. AND THE HANDLE WITH QUICK COUPLING IS BROKEN AT THE TOP OF THE HANDLE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A HANDLE WITH QUICK COUPLING. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11155096 ↗
• MalfunctionApr 15, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING ROUTINE INCOMING INSPECTION, IT WAS OBSERVED THAT THE HANDLE WITH QUICK COUPLING WAS DAMAGED WITH A BROKEN HANDLE. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9963770 ↗
• MalfunctionMar 11, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING INCOMING ROUTINE INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE HANDLE WITH QUICK COUPLING WAS BROKEN. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS 1 OF 1 FOR REPORT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9819929 ↗
• MalfunctionSep 16, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET, A HANDLE WITH QUICK COUPLING WAS OBSERVED BROKEN. THERE WAS NO PATIENT AND PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE (1) HANDLE WITH QUICK COUPLING. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9070866 ↗
• MalfunctionSep 12, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING PROCEDURE, THE SCRUB TECH WAS PUTTING THE T8 SCREWDRIVER ATTACHMENT ONTO THE HANDLE WITH QUICK COUPLING, THE END CAP FELL OFF ONTO THE FLOOR. SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT DELAY BY USING THE SCREWDRIVER WITHOUT THE ENDCAP. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: STARDRIVE SCREWDRIVER SHAFT T8 105 MM (PART #: 314.467, LOT # UNKNOWN, QUANTITY # 1). THIS REPORT IS FOR ONE (1) HANDLE WITH QUICK COUPLING. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9009681 ↗
• MalfunctionAug 23, 2019Break; Break

  IT WAS REPORTED THAT DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET ON AN UNKNOWN DATE, A HANDLE WITH QUICK COUPLING WAS BROKEN. THERE WAS NO PROCEDURE AND PATIENT INVOLVEMENT. THIS REPORT IS FOR A HANDLE WITH QUICK COUPLING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8926446 ↗
• MalfunctionMar 6, 2017Bent; Component Missing; Bent; Component Missing

  IT WAS REPORTED THAT DURING A ROUTINE INSPECTION OF FIELD EQUIPMENT THAT THE QUICK COUPLING HANDLE IS MISSING THE BACK PIECE (METAL KNOB/CAP) AT THE END OF THE HANDLE. THE KNOB/CAP FITS OVER FOUR PRONGS. IT WAS ALSO NOTED THAT ONE OF THE PRONGS APPEARS TO BE BENT. THE ISSUE WAS NOT NOTICED AT A HOSPITAL OR USED IN A CASE. THERE WAS NO PATIENT OR PROCEDURE INVOLVED. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6382870 ↗