NA 314.03Recalls & reported problems

Summary

The FDA's MAUDE database contains 91 adverse event reports that list this exact device (DI 10886982188380), received between Feb 14, 2017 and Mar 3, 2026 — classified as 4 injuries, 87 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (43 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 25 most recent of 91 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2026Material Twisted/Bent

  IT WAS REPORTED THE SCREWDRIVER SHAFTS WERE WORN; THE SCREWS WERE WOBBLING WHEN PUT IN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24497463 ↗
• MalfunctionMar 3, 2026Material Twisted/Bent

  IT WAS REPORTED THE SCREWDRIVER SHAFTS WERE WORN; THE SCREWS WERE WOBBLING WHEN PUT IN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24497447 ↗
• 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 24223718 ↗
• MalfunctionJan 20, 2026Material Twisted/Bent

  IT WAS REPORTED THE SCREWDRIVER HANDLES ARE LEAVING STAINS ON PEEL PACKS DURING STERILIZATION, THE TIP OF DEPTH GAUGE BROKE DURING CLEANING AND SCREWDRIVER SHAFT IS WORN OUT. EVENT WAS NOTED DURING STERILE PROCESSING AND FIELD INSPECTION. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24120674 ↗
• MalfunctionJan 13, 2026Material Twisted/Bent

  IT WAS REPORTED THAT TNA DRIVE CAP PIN CAME OUT WHEN MALLETING. VOLT BLUE HANDLE BROKE WHEN COUNTERSINKING. 11MM WRENCH BROKE WHEN TIGHTENING RFNA CAP. ALSO HAD TWO 2.5MM HEX STRIP AND TWO MEDIUM LOBSTER CLAW SPINDLE BENT. SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24059626 ↗
• MalfunctionJan 13, 2026Material Twisted/Bent

  IT WAS REPORTED THAT TNA DRIVE CAP PIN CAME OUT WHEN MALLETING. VOLT BLUE HANDLE BROKE WHEN COUNTERSINKING. 11MM WRENCH BROKE WHEN TIGHTENING RFNA CAP. ALSO HAD TWO 2.5MM HEX STRIP AND TWO MEDIUM LOBSTER CLAW SPINDLE BENT. SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24059616 ↗
• MalfunctionJan 8, 2026Material Twisted/Bent

  IT WAS REPORTED THE HEX SCREWDRIVER WAS STRIPPED. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24002254 ↗
• MalfunctionSep 18, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT SEVERAL SCREWDRIVER SHAFTS WERE WARPED AND NOT ABLE TO RETAIN SCREWS CORRECTLY. SALES REP WAS RESTOCKING TRAYS AND DISCOVERED THE DAMAGED SCREWDRIVERS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23085048 ↗
• MalfunctionApr 29, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING LOAN KIT INSPECTION, IT WAS NOTICED THAT THE PRODUCT WAS DAMAGED. UPON MANUFACTURERS INSPECTION THE PRODUCT WAS IDENTIFIED AS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21926733 ↗
• MalfunctionJan 28, 2025Material Discolored; Material Twisted/Bent; Material Discolored; Material Twisted/Bent

  IT WAS REPORTED THAT DURING POST OP INSPECTION, ITEMS WERE STRIPPED AND DISCOLORED FROM WASH OF CENTRAL STERILE PROCESSING DEPARTMENT (CSPD). THERE WAS NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21252632 ↗
• MalfunctionJan 28, 2025Material Discolored; Material Twisted/Bent; Material Discolored; Material Twisted/Bent

  IT WAS REPORTED THAT DURING POST OP INSPECTION, ITEMS WERE STRIPPED AND DISCOLORED FROM WASH OF CENTRAL STERILE PROCESSING DEPARTMENT (CSPD). THERE WAS NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21252629 ↗
• MalfunctionJan 27, 2025Material Discolored; Material Twisted/Bent; Material Discolored; Material Twisted/Bent

  IT WAS REPORTED THAT DURING POST OP INSPECTION, ITEMS WERE STRIPPED AND DISCOLORED FROM WASH OF CSPD. THERE WAS NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21245042 ↗
• MalfunctionSep 3, 2024Break; Break

  IT WAS REPORTED DURING A PROCEDURE ON (B)(6) 2024, THE METAL HAD COME OFF THE SCREWDRIVER. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. PATIENT STATUS WAS LISTED AS SATISFACTORY. THIS REPORT IS FOR ONE SMALL HEXAGONAL SCREWDRIVER SHAFT THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20125756 ↗
• MalfunctionAug 1, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN JULY 9, 2024, WHILE INVENTORYING THE SET IT WAS FOUND THAT THE SCREWDRIVER SHAFT WERE STUCK INSIDE THE SCREWDRIVER HANDLE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) SMALL HEXAGONAL SCREWDRIVER SHAFT. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19882811 ↗
• MalfunctionJul 24, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON JUNE 4, 2024, THERE WERE DAMAGED INSTRUMENTS. PROBE END IS BENT AND DENTED. HEX END OF SCREW SHAFT IS WARPED AND NOT USABLE. HOLDING SLEEVE DOES NOT CAPTURE OR SCREW ALL THE WAY TO CLOSE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A SMALL HEXAGONAL SCREWDRIVER SHAFT. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19819454 ↗
• MalfunctionJun 17, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024 DURING THE PROCEDURE, UPON REMOVING EXISTING HARDWARE, THE SCRUB TECH NEEDED TO SWAP THE SCREWDRIVER SHAFT THAT WAS CONNECTED TO THE QUICK COUPLING HANDLE FOR ANOTHER ONE. THE SCRUB TECH WAS NOT ABLE TO REMOVE THE 2.5 HEX SCREWDRIVER SHAFT FROM THE HANDLE. AFTER MULTIPLE UNSUCCESSFUL ATTEMPTS FROM BOTH THE SCRUB TECH AS WELL AS THE SURGEON, IT WAS DECIDED TO OPEN ANOTHER TRAY THAT HAD A QUICK COUPLING HANDLE AND THE PROCEDURE WAS PROCEEDED. ONCE THE PROCEDURE WAS COMPLETED, ANOTHER ATTEMPT WAS MADE TO REMOVE THE SCREWDRIVER SHAFT FROM THE HANDLE. THIS ALSO WAS UNSUCCESSFUL. THE SHAFT CONTINUES TO REMAIN ATTACHED TO THE HANDLE WITHOUT THE ABILITY TO DISASSEMBLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAYS, NEGATIVE OUTCOMES, OR INTERVENTION REQUIRED. THIS REPORT IS FOR ONE (1) LARGE HANDLE WITH QUICK COUPLING. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4). THIS REPORT IS FOR ONE (1) SMALL HEXAGONAL SCREWDRIVER SHAFT. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19554536 ↗
• MalfunctionNov 14, 2023Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT DURING THE PLANNING STAGE OF A VISIT TO THE ACCOUNT, THERE WAS FEEDBACK FROM OR STAFF THAT THE T8 DRIVER NEEDED TO BE REPLACED DUE TO DIFFICULTY ENGAGING THE SCREW HEAD. IT WAS ALSO REPORTED THAT OTHER ITEMS NEEDED TO BE INSPECTED DURING SALES REP VISIT. WITH THE LIMITED INFORMATION HE HAD AT THE TIME (ONLY ITEM # PROVIDED WAS THE T8 DRIVER), A PRODUCT COMPLAINT WAS CREATED TO MEET REPORTING GUIDELINES. ONCE HE TRAVELLED THE 4 HOURS TO THE ACCOUNT 2 DAYS LATER I PHYSICALLY INSPECTED THE SET WITH THEIR TEAM AND REPLACED ALL ITEMS THEY FELT SHOULD BE REPLACED. THE ATTACHMENT CONTAINED AN ADDITIONAL 20 ITEMS, 21 TOTAL INCLUDING THE T8 DRIVER, ALL OF WHICH HAVE BEEN REQUESTED TO BE REPLACED. THE ATTACHMENT PROVIDED IN THE UPDATE SHOULD CONTAIN ALL REQUIRED INFORMATION TO ADD THE 20 ITEMS TO THE COMPLAINT. THIS REPORT IS FOR ONE (1) SMALL HEXAGONAL SCREWDRIVER SHAFT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18132582 ↗
• MalfunctionNov 13, 2023Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED VIA FEEDBACK FROM OR STAFF THAT THE T8 DRIVER REQUIRED REPLACING DUE TO DIFFICULTY ENGAGING WITH SCREW HEADS. IT WAS ALSO REPORTED THAT OTHER ITEMS NEEDED TO BE INSPECTED DURING THE SALES REP VISIT. AFTER INSPECTION FROM THE SALES REP WAS COMPLETED, OTHER ITEMS WERE FOUND REQUIRING REPLACEMENT DUE TO THEIR BEING WORN. THERE WAS NO REPORTED PATIENT OR PROCEDURE INTERACTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A SMALL HEXAGONAL SCREWDRIVER SHAFT. THIS IS REPORT 4 OF 10 FOR: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18123165 ↗
• MalfunctionNov 13, 2023Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED VIA FEEDBACK FROM OR STAFF THAT THE T8 DRIVER REQUIRED REPLACING DUE TO DIFFICULTY ENGAGING WITH SCREW HEADS. IT WAS ALSO REPORTED THAT OTHER ITEMS NEEDED TO BE INSPECTED DURING THE SALES REP VISIT. AFTER INSPECTION FROM THE SALES REP WAS COMPLETED, OTHER ITEMS WERE FOUND REQUIRING REPLACEMENT DUE TO THEIR BEING WORN. THERE WAS NO REPORTED PATIENT OR PROCEDURE INTERACTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A SMALL HEXAGONAL SCREWDRIVER SHAFT. THIS IS REPORT 4 OF 10 FOR (B)(4) .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18121730 ↗
• MalfunctionSep 14, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2023, THE TIP IS WORN. NO PATIENT OR OPERATION INVOLVEMENT WAS REPORTED. THIS REPORT IS FOR ONE (1) SMALL HEXAGONAL SCREWDRIVER SHAFT THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17743706 ↗
• MalfunctionSep 6, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2023, DURING INTRA-OP THE SURGEON OBSERVED THAT THE PRODUCT CODE SMALL HEXAGONAL SCREWDRIVER SHAFT (314.02) IS NO LONGER PROVIDING PURCHASE ON THE SCREW HEAD AND WAS WORN OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. IT WAS UNKNOWN IF THERE WAS ANY FRAGMENTS ARE GENERATED. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) SMALL HEXAGONAL SCREWDRIVER SHAFT. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17691438 ↗
• MalfunctionSep 6, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6), 2023, DURING INTRA-OP THE SURGEON OBSERVED THAT THE PRODUCT CODE SMALL HEXAGONAL SCREWDRIVER SHAFT (314.02) IS NO LONGER PROVIDING PURCHASE ON THE SCREW HEAD AND WAS WORN OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. IT WAS UNKNOWN IF THERE WAS ANY FRAGMENTS ARE GENERATED. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) SMALL HEXAGONAL SCREWDRIVER SHAFT. THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17691430 ↗
• MalfunctionSep 6, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2023, DURING INTRA-OP THE SURGEON OBSERVED THAT THE PRODUCT CODE SMALL HEXAGONAL SCREWDRIVER SHAFT (314.02) IS NO LONGER PROVIDING PURCHASE ON THE SCREW HEAD AND WAS WORN OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. IT WAS UNKNOWN IF THERE WAS ANY FRAGMENTS ARE GENERATED. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) SMALL HEXAGONAL SCREWDRIVER SHAFT. THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17691353 ↗
• MalfunctionSep 6, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AUGUST 16, 2023, DURING INTRA-OP THE SURGEON OBSERVED THAT THE PRODUCT CODE SMALL HEXAGONAL SCREWDRIVER SHAFT (314.02) IS NO LONGER PROVIDING PURCHASE ON THE SCREW HEAD AND WAS WORN OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. IT WAS UNKNOWN IF THERE WAS ANY FRAGMENTS ARE GENERATED. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) SMALL HEXAGONAL SCREWDRIVER SHAFT. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17691346 ↗
• MalfunctionAug 31, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2023, THE SCREWDRIVERS IN QUESTION WERE NO LONGER PROVIDING PURCHASE ON THE SCREW HEAD AND ARE "WORN OUT". THERE WAS NO SURGICAL DELAY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO REPORTED ADVERSE PATIENT CONSEQUENCES/OUTCOMES. THIS REPORT IS FOR A SMALL HEXAGONAL SCREWDRIVER SHAFT. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17661840 ↗