NA 03.010.472Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 10886982068934), received between Mar 17, 2017 and Oct 9, 2024 — classified as 43 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (17 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 43 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 9, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE INSTRUMENT WAS PULLED FROM TRAY BECAUSE SPD NOTICED IT WAS BROKEN AND NOT WORKING CORRECTLY. THERE WERE NO PATIENT DETAILS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20409910 ↗
• MalfunctionOct 9, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE INSTRUMENT WAS PULLED FROM TRAY BECAUSE SPD NOTICED IT WAS BROKEN AND NOT WORKING CORRECTLY. THERE WERE NO PATIENT DETAILS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20409697 ↗
• MalfunctionOct 9, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE INSTRUMENT WAS PULLED FROM TRAY BECAUSE SPD NOTICED IT WAS BROKEN AND NOT WORKING CORRECTLY. THERE WERE NO PATIENT DETAILS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20409653 ↗
• MalfunctionSep 11, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT SCREWDRIVER TIP IS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20190332 ↗
• MalfunctionApr 13, 2023Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT DURING THE CLEANING PROCESS IT WAS DISCOVERED THAT SCREWDRIVERS ARE EXCESSIVELY WORN IN THE FRONT AREA. THERE WERE NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) INTER-LOCK SCREWDRIVER COMBINED T25/HEXA. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16731237 ↗
• MalfunctionMar 21, 2023Break; Break

  DEVICE REPORT FROM DEPUY SYNTHESE REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT A BROKEN SCREWDRIVER WAS DISCOVERED. UNKNOWN IF THE EVENT OCCUR DURING STERILE PROCESSING OR DURING FIELD INSPECTION. THIS COMPLAINT INVOLVES ONE(1) DEVICE THIS REPORT IS FOR ONE (1) INTER-LOCK SCREWDRIVER T25/3.5 HEX/330 THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16587605 ↗
• MalfunctionAug 1, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM THE UNITED KINGDOM REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE ITEMS SEEM TO HAVE BEEN AFFECTED BY THE HIGH TEMPERATURES OF THE WASHING/STERILIZATION PROCESS. SOME OF THE PLASTICS MELTED AND THE RUBBERS ON SOME TOOLS ARE OILY AND STICKY. THERE IS NO REPORTED PATIENT INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN INTER-LOCK SCREWDRIVER T25/3.5MM HEX/330MM. THIS IS REPORT 6 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15138058 ↗
• MalfunctionJun 15, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN BELGIUM AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE SCREWDRIVER WAS DELIVERED BROKEN. THERE WERE NO REPORTED PATIENT CONSEQUENCES, THIS REPORT INVOLVES ONE (1) INTER-LOCK SCREWDRIVER T25/3.5MM HEX/330MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14698859 ↗
• MalfunctionDec 21, 2021Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, A WEAR AND TEAR BREAKAGE OF A SELF HOLDING T25 SCREWDRIVER FROM A SCREW KEPT DISENGAGING AND THEY HAD TO OPEN ANOTHER INSTRUMENT SET. THE STAR DRIVE WAS TWISTED AROUND AND WOULD NOT HOLD A SCREW PROPERLY. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH TEN(10) MINUTES OF DELAY. NO PATIENT IMPACT. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). 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 13056337 ↗
• MalfunctionDec 1, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE INTER-LOCK SCREWDRIVER WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) INTER-LOCK SCREWDRIVER T25/3.5MM HEX/330MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12911776 ↗
• MalfunctionOct 25, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE SCREWDRIVER BROKE DURING CLEANING. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR (1) INTER-LOCK SCREWDRIVER T25/3.5MM HEX/330MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12692721 ↗
• MalfunctionOct 7, 2021Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SCREWDRIVER WAS FOUND TO BE STRIPPED DUE TO BEING OVERUSED. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES (1) INTER-LOCK SCREWDRIVER T25/3.5MM HEX/330MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12591519 ↗
• MalfunctionAug 18, 2021Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, (3) INTER-LOCK SCREWDRIVERS WERE FOUND TO BE DENTED ON THE TIPS. IT WAS REPORTED AS BEING A SIGN OF NORMAL WEAR AND TEAR. THERE WAS NO PATIENT OR SURGICAL INVOLVEMENT. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR (1) INTER-LOCK SCREWDRIVER T25/3.5MM HEX/330MM. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12339072 ↗
• MalfunctionAug 18, 2021Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THREE (3) INTER-LOCK SCREWDRIVERS WERE FOUND TO BE DENTED ON THE TIPS. IT WAS REPORTED AS BEING A SIGN OF NORMAL WEAR AND TEAR. THERE WAS NO PATIENT OR SURGICAL INVOLVEMENT. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) INTER-LOCK SCREWDRIVER T25/3.5MM HEX/330MM. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12339010 ↗
• MalfunctionNov 18, 2020Break; Material Twisted/Bent; Break; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE INTERLOCK SCREWDRIVER WAS FLAGGED AS BROKEN PRIOR TO SURGICAL USE. THE SCREWDRIVER HAD NOT BEEN REASSEMBLED PRIOR TO STERILIZATION. BEFORE THE CASE, THE SCRUB NURSE REASSEMBLED THE SCREWDRIVER. THEY NOTICED THE TIP WAS DEFORMED AND THE INSTRUMENT WAS UNUSABLE. IT IS UNKNOWN WHEN THE DAMAGE OCCURRED. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) INTER-LOCK SCREWDRIVER T25/3.5MM HEX/330MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10863036 ↗
• MalfunctionNov 10, 2020Material Twisted/Bent; Material Twisted/Bent

  CONCOMITANT DEVICE: SCREW (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1)

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10817819 ↗
• MalfunctionJul 2, 2020Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, DURING THE PLACEMENT OF THE EXPERT RETROGRADE/ANTEGRADE FEMORAL NAIL (RAFN), WHEN ATTEMPTING TO REMOVE THE PROXIMAL LATEROMEDIA LOCKING SCREW THE SCREWDRIVER BROKE. THE TIP BECAME DEFORMED. ANOTHER SCREWDRIVER WAS USED TO REMOVE THE SCREW. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO CONSEQUENCE TO THE PATIENT. CONCOMITANT DEVICE REPORTED: LOCKING SCREW (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN), EXPERT RAFN NAIL (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) INTER-LOCK SCREWDRIVER T25/3.5MM HEX/330MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10224021 ↗
• MalfunctionMay 25, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE WHILE RESTOCKING THE SETS IN CENTRAL STERILE SUPPLY (CSS), IT WAS DISCOVERED THAT THERE WERE 2 DAMAGED INSTRUMENTS IN THE EXCESS DEPUY SYNTHES INSTRUMENT DRAWER. THE TIP OF THE INTER-LOCK SCREWDRIVER WAS TWISTED AND NOT ALLOWING THE LOCKING MECHANISM TO FUNCTION PROPERLY. THEN, THE DEPTH PROBE WAS BROKEN OFF FROM THE BODY OF THE DEPTH GAUGE. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES 2 DEVICES. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10085262 ↗
• MalfunctionMay 5, 2020Break; Break

  IT WAS REPORTED ON AN UNKNOWN DATE, THE INTER-LOCK SCREWDRIVER IS BROKEN. THE INTERLOCK MECHANISM DOES NOT WORK. THERE WERE NO PATIENT AND SURGICAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) INTERLOCK-SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10024906 ↗
• MalfunctionMar 27, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE LOCKING MECHANISM DISTAL OF THE SCREWDRIVER BROKE. THE SCREWDRIVER BENDED WHILE USING, IT COULDN¿T HANDLE THE FORCE USED. THE ISSUE WAS DISCOVERED DURING A SURGICAL PROCEDURE, NO IMPACT TO THE PATIENT, A DIFFERENT SCREWDRIVER WAS USED TO COMPLETE THE PROCEDURE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9889094 ↗
• MalfunctionJan 30, 2020Break; Material Twisted/Bent; Break; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE TIGHTENING END OF SCREWDRIVER HAS TWISTED AND SNAPPED. THIS CASE HAS BEEN REPORTED BY THE LOAN KIT TECHNICIAN DURING LOAN KIT INSPECTION. IT HAS BEEN FORWARDED TO DEPUY ENGINEERING FOR ASSESSMENT. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER. THIS COMPLAINT INVOLVES ONE (1) DEVICES. THIS IS 1 OF 1 FOR REPORT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9647357 ↗
• MalfunctionOct 18, 2019Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TIP OF SCREWDRIVER IS TURNED AND CAN BE USED ANYMORE. THERE ARE NO PATIENT CONSEQUENCES. THIS REPORT IS FOR 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9208804 ↗
• MalfunctionOct 11, 2019Break; Break

  THIS IS REPORT IS 3 OF 6 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9181517 ↗
• MalfunctionOct 10, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING CLEANING IN THE STERILE PROCESSING DEPARTMENT ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE TIP OF AN INTER-LOCK SCREWDRIVER WAS SLIGHTLY TWISTED, AND THE SLIDING PIECE DOESN¿T FIT IN WHILE THE FLAT METAL SPRING OF A REDUCTION FORCEPS WAS FOUND TO BE COMPLETELY BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) INTER-LOCK SCREWDRIVER T25/3.5MM HEX/330MM. THIS IS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9175627 ↗
• MalfunctionSep 25, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE INTER-LOCK SCREWDRIVER WAS BROKEN DURING SCREW INSERTION AND WOULD NOT PROPERLY ENGAGE WITH THE SCREW HEAD DURING ORTHOPEDIC PROCEDURE. THERE WERE FRAGMENTS GENERATED FROM THE BROKEN DEVICE. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE CONCOMITANT DEVICE REPORTED: UNK - SCREWS: TRAUMA (PART # / LOT #: UNKNOWN, QUANTITY# 1) . THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) INTER-LOCK SCREWDRIVER T25/3.5 MM HEX/330 MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9119762 ↗