NA 03.010.150Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10886982067975), received between Jan 20, 2017 and Jan 30, 2026 — classified as 33 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (24 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2026Contamination /Decontamination Problem

  IT WAS REPORTED MULTIPLE COMPOSITE HANDLE TRAUMA PRODUCTS ARE LEAKING CAUSING STERILITY ISSUES. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24223889 ↗
• MalfunctionJan 26, 2026Material Twisted/Bent

  IT WAS REPORTED MULTIPLE DEVICES ARE NO LONGER FUNCTIONAL. THESE ISSUES DID NOT IMPACT PATIENT OUTCOMES. BELOW DEVICES WERE FOUND TO BE "RELEASE MECHANISM BROKEN" DURING INSPECTION: 03.043.028. BELOW DEVICES WERE FOUND TO BE "STRIPPED THREADS" DURING INSPECTION: 03.120.022. 312.648. 323.029. BELOW DEVICES WERE FOUND TO BE "NUT STUCK ON SLEEVE" DURING INSPECTION: 03.037.017. 03.037.016. BELOW DEVICES WERE FOUND TO BE "HANDLE LEACHING/SPD WIL NOT STERILIZE" DURING INSPECTION: 03.100.018. BELOW DEVICES WERE FOUND TO BE "BROKEN HANDLE" DURING INSPECTION: 311.43. BELOW DEVICES WERE FOUND TO BE "STRIPPED DRILL CONNECTION AND 2ND IS COLD WELDED TO A SCHANZ PIN" DURING INSPECTION: 393.103. BELOW DEVICES WERE FOUND TO BE "BROKEN SLIDING MECHANISM" DURING INSPECTION: 319.091. BELOW DEVICES WERE FOUND TO BE "NOT SNAPPING IN" DURING INSPECTION: 03.120.018. 03.120.017. BELOW DEVICES WERE FOUND TO BE "STRIPPED" DURING INSPECTION: 03.010.151. 314.467. 03.900.042. 03.130.010. 314.453. 03.010.150. 03.010.152. BELOW DEVICES WERE FOUND TO BE "NOT WORKING PROPERLY" DURING INSPECTION: 329.15. BELOW DEVICES WERE FOUND TO BE "NOT LOCKING TENSION BETWEEN TRIGGER PULLS" DURING INSPECTION: 03.221.015. BELOW

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24180131 ↗
• MalfunctionMay 30, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THE SCREWDRIVER WAS STRIPPED AND STUCK. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22116489 ↗
• MalfunctionJan 31, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE SCREWDRIVER HEADS ARE STRIPPED. THEY DO NOT ENGAGE SCREW HEADS PROPERLY ANYMORE. THE REPLACEMENT SCREWDRIVER WAS USED TO PROCEED WITH THE PROCEDURE. THERE WAS A TWO MINUTES OF SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21285331 ↗
• MalfunctionNov 20, 2024Detachment of Device or Device Component; Material Twisted/Bent; Detachment of Device or Device Component; Material Twisted/Bent

  IT WAS REPORTED, THAT DURING A PROCEDURE. WHEN SURGEON WAS TIGHTENING THE SCREW INTO THE PLATE, SURGEON FELT A PING. AND NOTICED, THAT A SMALL SILVER PIN DROP TO THE FLOOR. THE SCREWDRIVER BECAME UNSTABLE AND WOULD NOT TIGHTEN SCREW, DUE TO THE SHAFT BEING NO LONGER FIXED TO HANDLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20738829 ↗
• MalfunctionOct 31, 2023Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ROUTINE INSPECTION INDICATED WEAR AND DAMAGE THERE WERE NO PATIENT OUTCOMES OR CONSEQUENCES. THIS REPORT IS FOR ONE (1)SCRDRIVER-HEX Ø3.5 COMBINED W/STARDR T25 THIS IS REPORT 5 OF 5 FOR COMPLAINT PC-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18042426 ↗
• MalfunctionOct 31, 2023Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ROUTINE INSPECTION INDICATED WEAR AND DAMAGE THERE WERE NO PATIENT OUTCOMES OR CONSEQUENCES. THIS REPORT IS FOR ONE (1)SCRDRIVER-HEX Ø3.5 COMBINED W/STARDR T25. THIS IS REPORT 3 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18042336 ↗
• MalfunctionOct 20, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2023 SCREWDRIVER WAS REPORTED BY THE CUSTOMER AS WORN AND NO LONGER ABLE TO HOLD PURCHASE ON THE SCREW. UPON INSPECTION, IT APPEARS THERE IS SIGNIFICANT WEAR AND TEAR AROUND THE END OF THE SCREWDRIVER. NO FRAGMENTS WERE GENERATED. SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. PATIENT OUTCOME WAS UNKNOWN. THIS REPORT IS FOR ONE (1) SD/HD SCRDRIVER T25 3.5 HEX/SELF-RETAIN. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17974959 ↗
• MalfunctionOct 20, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2023 SCREWDRIVER WAS REPORTED BY THE CUSTOMER AS WORN AND NO LONGER ABLE TO HOLD PURCHASE ON THE SCREW. UPON INSPECTION, IT APPEARS THERE IS SIGNIFICANT WEAR AND TEAR AROUND THE END OF THE SCREWDRIVER. NO FRAGMENTS WERE GENERATED. SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. PATIENT OUTCOME WAS UNKNOWN. THIS REPORT IS FOR ONE (1) SD/HD SCRDRIVER T25 3.5 HEX/SELF-RETAIN THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17974956 ↗
• MalfunctionOct 20, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2023 SCREWDRIVER WAS REPORTED BY THE CUSTOMER AS WORN AND NO LONGER ABLE TO HOLD PURCHASE ON THE SCREW. UPON INSPECTION, IT APPEARS THERE IS SIGNIFICANT WEAR AND TEAR AROUND THE END OF THE SCREWDRIVER. NO FRAGMENTS WERE GENERATED. SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. PATIENT OUTCOME WAS UNKNOWN. THIS REPORT IS FOR ONE (1) SD/HD SCRDRIVER T25 3.5 HEX/SELF-RETAIN THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17974947 ↗
• MalfunctionAug 30, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, THE SCREWDRIVERS IN QUESTION WERE FOUND TO NO LONGER INTERFACE PROPERLY WITH SCREW HEADS AND WOULD SLIP WHEN TRYING TO TIGHTEN SCREWS. THERE WAS NO SURGICAL DELAY, THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A STAR/HEXDRIVE SCREWDRIVER T25 3.5MM HEX/SELF-RETAINING. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17651322 ↗
• MalfunctionAug 30, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, THE SCREWDRIVERS IN QUESTION WERE FOUND TO NO LONGER INTERFACE PROPERLY WITH SCREW HEADS AND WOULD SLIP WHEN TRYING TO TIGHTEN SCREWS. THERE WAS NO SURGICAL DELAY, THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A STAR/HEXDRIVE SCREWDRIVER T25 3.5MM HEX/SELF-RETAINING. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17651317 ↗
• MalfunctionAug 30, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON 16-AUGUST-2023, THE SCREWDRIVERS IN QUESTION WERE FOUND TO NO LONGER INTERFACE PROPERLY WITH SCREW HEADS AND WOULD SLIP WHEN TRYING TO TIGHTEN SCREWS. THERE WAS NO SURGICAL DELAY, THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A STAR/HEXDRIVE SCREWDRIVER T25 3.5MM HEX/SELF-RETAINING. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17651303 ↗
• MalfunctionAug 30, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, THE SCREWDRIVERS IN QUESTION WERE FOUND TO NO LONGER INTERFACE PROPERLY WITH SCREW HEADS AND WOULD SLIP WHEN TRYING TO TIGHTEN SCREWS. THERE WAS NO SURGICAL DELAY, THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A STAR/HEXDRIVE SCREWDRIVER T25 3.5MM HEX/SELF-RETAINING. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17651293 ↗
• MalfunctionMar 3, 2023Material Twisted/Bent; Material Twisted/Bent

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16477021 ↗
• MalfunctionMar 1, 2023Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM DEPUY SYNTHESE REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT THE TIPS OF BOTH INSTRUMENTS WERE BOTH ROUNDING OFF VS HAVING IDENTIFIED T25 STAR TIP. THIS REPORT IS FOR ONE (1) SCRDRIVER-HEX Ø3.5 COMBINED W/STARDR T25 THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16462092 ↗
• MalfunctionJan 13, 2023Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT THE INSTRUMENT ROOM TECHNICIAN NOTED A WORN TIP OF THE SCREWDRIVER. THE REPORTED ISSUE IDENTIFIED PRIOR TO BEING RE-PROCESSED. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) SD/HD SCRDRIVER T25 3.5 HEX/SELF-RETAIN. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16162511 ↗
• MalfunctionJun 28, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE STARDRIVE SHAFT TIP TWISTED AND TORQUED, AND IS UNABLE TO BE USED. THE HOSPITAL PROVIDED THE INSTRUMENTATION TO THE SALES REP WITHOUT ANY EXPLANATION ON EVENT OR CASE INFORMATION. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. PATIENT AND PROCEDURE INVOLVEMENT ARE UNKNOWN. THIS REPORT IS FOR A STAR/HEXDRIVE SCREWDRIVER T25 3.5MM HEX/SELF-RETAINING. THIS IS REPORT 1 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14842135 ↗
• MalfunctionApr 26, 2022Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, WHILE INSPECTING THE INSTRUMENTS AFTER GOING THROUGH THE DECONTAMINATION PROCESS THE SALES CONSULTANT NOTICED THERE WERE THREE(3) INSTRUMENTS THAT WERE DAMAGED AND NEED REPLACED. THE SD/HD SCRDRIVER T25 3.5 HEX/SELF-RETAIN, WHILE LOCK A SCREW INTO THE PLATE WITH IT THE HANDLE STARTS TO SPIN ON THE SHAFT. RED FORCEPS POINTS NARROW-RATCHET 132, THIS ITEM'S TIP IS BEND AND WILL NOT HOLD THE POINTS TOGETHER. RED FORCEPS POINTS NARROW-RATCHET 132, THIS ITEMS TIPS ARE BEND AND WILL NOT COME TOGETHER. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES THREE(3) DEVICES, ONE (1) REPORTABLE SD/HD SCRDRIVER T25 3.5 HEX/SELF-RETAIN. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14211239 ↗
• MalfunctionJul 22, 2021Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SCREWDRIVER TIP WAS DEFECTIVE. THIS WAS DISCOVERED DURING AN UNKNOWN PROCEDURE. PROCEDURE WAS DELAYED BY FIVE MINUTES. NO FURTHER INFORMATION. THIS REPORT IS FOR (1) STAR/HEXDRIVE SCREWDRIVER T25 3.5MM HEX/SELF-RETAINING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12210804 ↗
• MalfunctionJul 21, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2021, TWO (2) STAR/HEX DRIVE SCREWDRIVER, ONE (1) DRIVING CAP/THREADED, ONE (1) LONG SCALPEL HANDLE, ONE (1) CANNULATED HEXAGONAL SCREWDRIVER, AND ONE (1) HEXAGONAL SCREWDRIVER WERE DAMAGED PRODUCTS. IT IS UNKNOWN IF THERE WERE PATIENT AND PROCEDURE INVOLVEMENT. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) STAR/HEXDRIVE SCREWDRIVER T25 3.5MM HEX/SELF-RETAINING. THIS IS REPORT 2 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12203885 ↗
• MalfunctionJul 21, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2021, (2) STAR/HEX DRIVE SCREWDRIVER, (1) DRIVING CAP/THREADED, (1) LONG SCALPEL HANDLE, (1) CANNULATED HEXAGONAL SCREWDRIVER, AND (1) HEXAGONAL SCREWDRIVER WERE DAMAGED PRODUCTS. IT IS UNKNOWN IF THERE WERE PATIENT AND PROCEDURE INVOLVEMENT. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR (1) STAR/HEXDRIVE SCREWDRIVER T25 3.5MM HEX/SELF-RETAINING. THIS IS REPORT 1 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12203716 ↗
• MalfunctionJun 29, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING FIELD INSPECTION AND STERILE PROCESSING, ALL THE SIMILI WOOD HANDLE OF THE SCREWDRIVER ARE LEAVING RESIDUE IN THE PEEL PACK. A BROWN SPOT MAKING THE RESPONSIBLE THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS REPORT IS FOR ONE (1) STARDRIVE SCREWDRIVER T25. THIS REPORT IS 5 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12084057 ↗
• MalfunctionApr 14, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A PROCEDURE, A T25/3.5 HEX SCREWDRIVER DID NOT WORK FOR ITS INTENDED LARGE FRAG SCREWS. THE PURPOSE OF THE SCREWDRIVER IS TO BE USED WITH BOTH STAR AND HEX SCREWS BUT IT ONLY WORKS FOR THE STAR SCREWS. THE THREADS HAVE STRIPPED AND ARE NOT WORKABLE. THE SURGERY WAS DELAYED FOR FIVE (5) MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) STAR/HEXDRIVE SCREWDRIVER T25 3.5MM HEX/SELF-RETAINING THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11667920 ↗
• MalfunctionFeb 25, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING INSPECTION, IT WAS NOTICED THAT THE TIP OF THE STAR/HEXDRIVE SCREWDRIVER T25 IS TWISTED. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) STAR/HEXDRIVE SCREWDRIVER T25 3.5MM HEX/SELF-RETAINING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11381843 ↗