NA 03.010.473Recalls & reported problems

Summary

The FDA's MAUDE database contains 142 adverse event reports that list this exact device (DI 10886982068941), received between Feb 28, 2017 and Sep 25, 2026 — classified as 1 injury, 141 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (60 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 142 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Device-Device Incompatibility; Material Deformation

  It was reported that on (b)(6), 2026, the patient underwent unknown surgery using MHN long with the product in question. When attempting to assemble the device, it was found that the tip of the Screwdriver was slightly bent, preventing proper assembly.Another Screwdriver was used for the surgery. The surgery was completed successfully without any surgical delay. No further information is available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50900385 ↗
• MalfunctionMay 12, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT UNDERWENT ORIF SURGERY ON HUMERUS WITH THE PRODUCT IN QUESTION AND MULTI LOCK LONG. IN THE SURGERY, A NURSE WAS ASKED TO ASSEMBLE THE SCREWDRIVER IN QUESTION, BUT THEY WERE UNABLE TO DO SO, MAKING IT UNUSABLE. ANOTHER SCREWDRIVER WAS USED AS A SUBSTITUTE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25152632 ↗
• MalfunctionOct 27, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED INSTRUMENT 03.010.473 WAS DEFECTIVE IN THE LOAN SET AND COULD NOT BE USED DURING THE PROCEDURE. ALTHOUGH THERE WAS NO IMPACT ON THE PATIENT, THIS ISSUE SHOULD HAVE BEEN IDENTIFIED DURING THE INSPECTION. THE SURGEON AND THE SALES REPRESENTATIVE HAD TO USE AN ALTERNATIVE INSTRUMENT TO PROCEED WITH THE INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23392527 ↗
• MalfunctionMay 30, 2025Break; Break

  IT WAS REPORTED THE SCREWDRIVER IS SNAPPED OFF. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22116532 ↗
• MalfunctionMar 25, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TIP OF THE SCREWDRIVER WAS BENT AND WOULD NOT FIT INTO SCREWS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21688572 ↗
• MalfunctionFeb 13, 2025Break; Break

  IT WAS REPORTED THAT THE SCREWDRIVER'S TIP WAS BROKEN. THERE WAS NO PATIENT HARM OR SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21375151 ↗
• MalfunctionJan 2, 2025Break; Break

  IT WAS REPORTED THE SCREWDRIVER BROKE.

  Patient problems: Insufficient Information

  MAUDE report 21055012 ↗
• MalfunctionDec 20, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT WHILE INSPECTING THE INSTRUMENTATION AFTER GOING THROUGH THE DECONTAMINATION PROCESS, IT WAS NOTICED THAT THERE WERE SEVERAL GRAPHIC CASES AND SEVERAL INSTRUMENTS THAT WERE DAMAGED. IT WAS UNKNOWN WHEN THESE ITEMS WERE DAMAGED OR HOW THEY WERE DAMAGED. THERE IS NO PATIENT INVOLVEMENT AND IT IS UNKNOWN WHEN THE DAMAGE OCCURRED AND WHETHER IT WAS PREOP, POSTOP OR INTRAOP. ALL OF THESE ITEMS WERE NOTICED DAMAGED AFTER GOING THROUGH THE DECONTAMINATION PROCESS. 1. DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS: THIS ITEM IS A DEPTH GAUGE, AND THE TIP OF IT IS BROKEN. 2. SILICONE HNDL/QC ROTATING CAP: THE ITEM IS A SCREWDRIVER, AND THE BACK OF THE SCREWDRIVER HAS A CAP ON IT THAT IS BROKEN, AND IT APPEARS AS THOUGH THE PIECE IS CONNECTING THE CAP ARE BROKEN AND UNABLE TO BE USED. 3. CABLE CUTTER: THIS ITEM IS A CRIMPER FOR OUR CABLE SET AND ONE OF THE TIPS OF THE CRIMP IS BROKEN. 4. INTER-LOCK SCREWDRIVER T25/3.5 HEX/224: THE SIDE WAS A CAPTURE SCREWDRIVER, AND ONE OF THE SIDES OF THE CAPTURE PIECES IS TWISTED AND STRIPPED. 5. DRIVING CAP: THIS ITEM IS A DRIVING CAP FOR THE TIBIAL NAIL SYSTEM. THERE IS A SPOT WELD ON A PIN, AND THAT SPOT WELD HAS COME UNDONE AND ALLOWS A PI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20989123 ↗
• MalfunctionNov 14, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE REPORTED TIP IS BROKEN. NO OTHER INFORMATION WAS PROVIDED AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 20682943 ↗
• MalfunctionSep 24, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT DURING ON (B)(6) 2024, THE TIP OF THE SCREWDRIVER WAS WORN AND DAMAGED, AND FAILED TO ENGAGE PROPERLY WITH THE SCREW HEAD. THERE WAS A FIVE-MINUTE DELAY TO SURGERY AS A LONGER SCREWDRIVER HAD TO BE USED, WHICH WAS A LITTLE LESS AGILE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20290865 ↗
• MalfunctionSep 5, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS NOTED ON (B)(6) 2024 THE SCREWDRIVER WAS NOT CAPTURING THE SCREWS ANYMORE. IT IS UNKNOWN WHEN THE DEVICE MALFUNCTIONED. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE SCREWDRIVER FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 20148678 ↗
• MalfunctionApr 29, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS FURTHER REPORTED THAT DRILLS HAVE BEEN BROKEN BY SURGEONS BECAUSE ONE MEASURING INSTRUMENT WAS MISSING. SCREWDRIVER WAS ¿PROBLEMATIC¿ FROM THE BEGINNING OF THE SURGERY. TWO PIECES WERE BENT AND SO THE INSTRUMENT WAS NOT WORKING CORRECTLY. PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY AS BROKEN PIECES HAD TO BE REMOVED FROM THE PATIENT AND ALTERNATIVES/SOLUTIONS HAD TO BE FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19201909 ↗
• MalfunctionApr 17, 2024Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED A SCREWDRIVER WAS FOUND DAMAGED. THE TEETH ON THE STAR DRIVE TIP WERE WORN/BENT TO THE POINT THE DRIVER COULD NO LONGER RETAIN SCREWS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE INTER-LOCK SCREWDRIVER T25/3.5MM HEX/224MM FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19124431 ↗
• MalfunctionMar 20, 2024Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT AN OPEN REDUCTION/INTERNAL FIXATION SURGERY WITH THE MHN-LONG IMPLANT FOR A DISTAL HUMERAL SHAFT FRACTURE ON (B)(6) 2024. WHILE A DISTAL SCREW WAS BEING INSERTED, A STRANGE SOUND LIKE METAL MATERIAL BROKE WENT OFF, AND JUST THEN THE SCREW CAME OFF FROM A SCREWDRIVER TIP. THE IMAGE INTENSIFIER CONFIRMED NO FRAGMENTS WERE LEFT IN THE PATIENT¿S BODY. THE SCREWDRIVER TIP SEEMED TO BE SOMEHOW DISTORTED, SO ANOTHER SCREWDRIVER WAS USED INSTEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH AN ADDITIONAL 30 MINUTES. THE PATIENT OUTCOME WAS REPORTED TO BE STABLE. THIS REPORT INVOLVES ONE INTER-LOCK SCREWDRIVER T25/3.5MM HEX/224MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18942349 ↗
• MalfunctionJan 19, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IN JANUARY 2024, THE 3PC SCREWDRIVER TIP WAS COMPLETELY BENT SO THE INSERT DIDN¿T¿ FIT INSIDE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE INTER-LOCK SCREWDRIVER T25/3.5MM HEX/224MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18545977 ↗
• MalfunctionNov 3, 2023Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT AN UNKNOWN SURGERY. BEFORE SURGERY, THE SALES REP DEMONSTRATED THE PRODUCT BEFORE SURGERY. DURING DEMONSTRATION, THE SCREWDRIVER COULD NOT GRASP AND LOCK A SCREW PROPERLY. DEFORMATION OR DAMAGE OF COMPONENT PARTS WAS SUSPECTED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. PATIENT STATUS/OUTCOME: STABLE NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) INTER-LOCK SCREWDRIVER COMBINED T25/HEXA THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18068408 ↗
• MalfunctionJun 21, 2023Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023, THAT THE SCREW DRIVER DID NOT HOLD PROPERLY AND CAUSED DRIVER TO STRIP. THERE WAS SURGICAL DELAY DUE TO REPORTED EVENT FOR 5 MINUTES. THE SAME DRIVER WAS USED WITH EXTREME CARE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. THERE WERE NO PATIENT OUTCOME OR CONSEQUENCES. THIS REPORT IS FOR ONE (1) INTER-LOCK SCREWDRIVER T25/3.5 HEX/224. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17170243 ↗
• MalfunctionJun 19, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM THE UNITED KINGDOM REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, AN INTER-LOCK SCREWDRIVER WAS DISASSEMBLED FOR CLEANING. THE TIP OF THE DEVICE APPEARED TO BE DAMAGED AND THE DEVICE WAS UNABLE TO BE REASSEMBLED. THIS REPORT IS FOR AN INTER-LOCK SCREWDRIVER T25/3.5MM HEX/224MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17154168 ↗
• MalfunctionMay 10, 2023Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT SURGERY TFNA INTER-LOCK SCREWDRIVER. TO INSERT THE DISTAL LOCKING SCREW, THE NURSE ATTEMPTED TO ASSEMBLE THE SCREWDRIVER, BUT THE SCREWDRIVER SHAFT AND SCREW HEAD DID NOT LOCK. THE SURGEON TRIED, BUT THE RESULT WAS THE SAME, SO HE CHECKED THE SCREWDRIVER SHAFT AND FOUND THAT IT WAS BROKEN. FINALLY, THE SCREW WAS INSERTED WITH A REGULAR T25 SCREWDRIVER. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) INTER-LOCK SCREWDRIVER COMBINED T25/HEXA THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16907230 ↗
• MalfunctionMay 4, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6)2023, THE SCREWDRIVER WAS BROKEN. IT DEVELOPED A SMALL CRACK AT THE TIP. THIS WAS OBSERVED POSTOPERATIVELY. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE INTER-LOCK SCREWDRIVER T25/3.5MM HEX/224MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16870281 ↗
• MalfunctionMay 3, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023, OF A BROKEN SELF-CAPTURE SCREW DRIVER. THEY HAD ANOTHER SCREWDRIVER ON THE SET, SO NO EXTRA TIME WAS ADDED TO THE CASE. THIS REPORT IS FOR ONE (1) INTER-LOCK SCREWDRIVER COMBINED T25/HEXA THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16860052 ↗
• MalfunctionMar 1, 2023Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023, THAT SCREWDRIVER TWISTED AT THE TIP. NO HARM HAS BEEN CAUSED TO A PATIENT AND THE OPERATION WAS SUCCESSFULLY COMPLETED AS THEY HAD AN ALTERNATIVE SCREW AVAILABLE. CONCOMITANT DEVICE REPORTED: UNK - SCREWS: TRAUMA(PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) INTER-LOCK SCREWDRIVER COMBINED T25/HEXA. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16463689 ↗
• MalfunctionDec 22, 2022Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM GERMANY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, A CUSTOMER REPORTED A DAMAGED/NOT WORKING SCREWDRIVER AFTER MULTIPLE USES. THERE WAS NO REPORTED PATIENT HARM OR SURGICAL DELAY. UPON MANUFACTURER INVESTIGATION, IT WAS DETERMINED THAT THE CLAMP WAS MISSING. ADDITIONALLY, THE TIP OF THE DRIVER EXHIBITED SIGNS OF WEAR. THIS REPORT IS FOR AN INTER-LOCK SCREWDRIVER T25/3.5MM HEX/224MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16035014 ↗
• MalfunctionOct 17, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022 SEVERAL INSTRUMENTS WERE BROKEN. NO PATIENT INVOLVEMENT WAS REPORTED. NO ADDITIONAL INFORMATION WAS REPORTED. THIS REPORT IS FOR ONE (1) INTER-LOCK SCREWDRIVER T25/3.5 HEX/224. THIS IS REPORT 3 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15619782 ↗
• MalfunctionOct 11, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS FURTHER REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15575101 ↗