NA 314.451Recalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 10886982188847), received between Jan 18, 2017 and Sep 14, 2026 — classified as 2 injuries, 51 malfunctions.

The most frequently reported specific device problem is “Break” (28 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 53 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026Material Twisted/Bent

  It was reported that the screwdriver shaft in loan set is damaged and not loading screws. There was no surgical delay or patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50753602 ↗
• 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 23085183 ↗
• MalfunctionJul 23, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2025, THE SCREW DRIVERS AND ONE HANDLE ARE BROKEN, NEED REPLACEMENT ASAP. DRIVER TIPS ARE TWISTED AND HAVE DAMAGED THREADS. SCREW DRIVER HANDLE IS STUCK AND WILL NOT RELEASE. ITEMS ARE AVAILABLE FOR RETURN. NO DELAY OR PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22577565 ↗
• MalfunctionMar 28, 2025Break; Mechanical Problem; Break; Mechanical Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT HARDWARE REMOVAL ON AN UNKNOWN DATE IN 2025. DURING THE CASE, THE SCREWDRIVER SHAFT WAS TURNING IN THE QC HANDLE DURING CASE. IT WAS ALSO MENTIONED THAT THE BACK END OF THE SCREWDRIVER WAS BROKEN OFF. THEY WERE ABLE TO USE A DIFFERENT SCREWDRIVER TO COMPLETE THE CASE. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: Insufficient Information

  MAUDE report 21719035 ↗
• MalfunctionFeb 6, 2025Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE DEVICE WAS BRAND NEW AND BROKE THE 1ST TIME THEY USED IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21324442 ↗
• MalfunctionDec 12, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024 THE HANDLE STUCK TO DRIVESHAFT. THE EVENT OCCUR DURING STERILE PROCESSING AND FIELD INSPECTION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20921200 ↗
• MalfunctionJul 1, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SCREWDRIVER SHAFT JAMMED INTO THE WRONG HANDLE TO COVER CASE. IT IS NOW STUCK AND WON'T COME OUT. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES. THIS REPORT IS FOR ONE (1) 2.4MM SDDRIVE SCREWDRIVER SHAFT. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19645685 ↗
• MalfunctionJan 24, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: THIS INSTRUMENT IS COMPOSED OF 1 PART. THE INSTRUMENT IS BURRED AND UNABLE TO PICK THE SCREW FOR TIGHTENING. THE PRODUCT DAMAGE DOCUMENTED HAD BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. NO FURTHER INFORMATION CAN BE OBTAINED. THIS REPORT IS FOR ONE (1) SCRDRIVER SHAFT 2.4 SHORT SELF-HOLDING. THIS IS REPORT 1 OF 1 FOR COMPLAINT: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18570976 ↗
• MalfunctionDec 27, 2023Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE SCREWDRIVER WAS DAMAGED AND REQUIRED REPLACEMENT. NO FURTHER DETAILS WERE PROVIDED OR AVAILABLE. PATIENT OUTCOMES AND CONSEQUENCES ARE UNKNOWN. THIS REPORT IS FOR ONE (1) SCRDRIVER SHAFT 2.4 SHORT SELF-HOLDING. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18400626 ↗
• MalfunctionNov 29, 2023Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6), 2023, THE T8 SCREWDRIVER SHAFT THAT WAS PART OF A SCREW REMOVAL SET THAT WAS DELIVERED FOR THE SURGEON'S CASE WAS BROKEN PRIOR TO USE. THE SHAFT HAD SCRAPE IN IT THAT PREVENTED IT FROM BEING ABLE TO BE FULLY INSERTED INTO THE MINI QC HANDLE. THEY HAD TO PUT THIS SHAFT ON A T HANDLE CHUCK IN ORDER TO USE IT. THERE WAS A LESS THAN FIVE (5) MINUTES SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. NO PATIENT CONSEQUENCE WAS REPORTED. THIS REPORT IS FOR ONE (1) 2.4MM STARDRIVE SCREWDRIVER SHAFT THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18231978 ↗
• MalfunctionNov 8, 2023Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, THE SCREWDRIVERS IN QUESTION WERE FOUND TO BE WORN AND WOULD NOT HOLD THE SCREWS WELL. THE PROCEDURE WAS ABLE TO BE COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY USING ANOTHER SCREWDRIVER. THERE WAS NO ADVERSE PATIENT IMPACT. THIS REPORT IS FOR A 2.4MM STARDRIVE SCREWDRIVER SHAFT. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18091830 ↗
• MalfunctionSep 21, 2023Break; Break

  IT WAS FURTHER REPORTED THAT THE SCREW HEADS HAD TO BE FITTED WITH A CARBON DRILL BIT BE MILLED FROM THE OSTEOSYNTHESIS PLATE. THERE WERE 2 SCREW SHAFTS LEFT IN THE PATIENT'S BONE AND OVER DRILLING WAS NOT POSSIBLE AS IT WOULD HAVE DAMAGED THE BONE. THE OPERATION/ANESTHESIA TIME WAS ESTIMATED TO BE EXTENDED BY 30-40 MINUTES. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17789426 ↗
• MalfunctionAug 15, 2023Break; Break

  THE INSTRUMENT BROKE DURING A REMOVAL AND WAS NOT NOTICED UNTIL THE SET WAS RETURNED BACK TO THE METRO OFFICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17548833 ↗
• MalfunctionJul 10, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023, THE SCREWDRIVERS WERE BROKEN IN REMOVING A SCREW. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH 20MIN OF SURGICAL DELAY. NO FRAGMENTS WERE GENERATED. THIS REPORT IS FOR ONE (1) 2.4MM SDDRIVE SCREWDRIVER SHAFT THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17292363 ↗
• MalfunctionJul 10, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023, THE SCREWDRIVERS WERE BROKEN IN REMOVING A SCREW. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH 20MIN OF SURGICAL DELAY. NO FRAGMENTS WERE GENERATED. THIS REPORT IS FOR ONE (1) 2.4MM SDDRIVE SCREWDRIVER SHAFT THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17292299 ↗
• MalfunctionJun 1, 2023Break; Detachment of Device or Device Component; Device-Device Incompatibility; Break; Detachment of Device or Device Component; Device-Device Incompatibility

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, WHEN THE SCREWDRIVER SHAFT IN QUESTION WAS MOUNTED TO THE SCREWDRIVER HANDLE, IT WAS NOT ABLE TO CONNECT AS INTENDED. THE TOOTHED PART WAS SPLIT. THIS REPORT IS FOR A 2.4MM STARDRIVE SCREWDRIVER SHAFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17038081 ↗
• MalfunctionMay 31, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2023, THERE WERE PROBLEMS WITH THE METAL REMOVAL OF A DORSAL DISTAL TIBIAL PLATE. THE REASON FOR THE ATTEMPTED HARDWARE REMOVAL WAS THAT THE PATIENT WANTED THE MATERIAL REMOVED FROM OSTEOSYNTHESES IN 2020. SEVERAL SCREWDRIVERS/ATTACHMENTS WERE DEMOLISHED WHILE TRYING TO REMOVE THE SCREWS. THE PHYSICIAN WAS UNHAPPY THAT THE SCREWS HAD TO REMAIN IN THE PATIENT, AND THERE WAS A SURGICAL DELAY OF APPROXIMATELY ONE HOUR. NO OTHER MEDICAL INTERVENTION WAS REQUIRED, BUT THE SURGERY WAS NOT COMPLETED SUCCESSFULLY, AS THE OSTEOSYNTHESIS MATERIAL REMAINED IN THE BONE. AFTER VISUAL EXAMINATION OF THE RETURNED PRODUCTS ON (B)(6) 2023, IT WAS FOUND THAT ADDITIONAL DEVICES WERE STRIPPED. THIS REPORT INVOLVES ONE 2.4MM STARDRIVE SCREWDRIVER SHAFT. THIS IS REPORT 6 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17031773 ↗
• MalfunctionFeb 7, 2023Break; Break

  IT WAS REPORTED THAT ON JANUARY 18, 2023, THE INSTRUMENT WERE FOUND BROKEN IN STERILE PROCESSING. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) 2.4MM SDDRIVE SCREWDRIVER SHAFT. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16315153 ↗
• MalfunctionDec 23, 2022Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SWITZERLAND REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PRIOR TO A PROCEDURE ON (B)(6) 2022, A SCREWDRIVER WAS NOT WORKING AND NEEDED REPAIR. THERE WAS NO PATIENT INVOLVEMENT. UPON MANUFACTURER INVESTIGATION, IT WAS DETERMINED THAT THE DEVICE WAS WORN FROM REPEATED USE AND SERVICING. THIS REPORT IS FOR A 2.4MM STARDRIVE SCREWDRIVER SHAFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16042945 ↗
• MalfunctionDec 12, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT WHILE RESTOCKING THE INSTRUMENT TRAY ON AN UNKNOWN DATE, THE SCREWDRIVER TIP WAS DAMAGED AND NOT USEABLE. THERE WAS NO PATIENT INVOLVEMENT. UPON MANUFACTURER INVESTIGATION, IT WAS DETERMINED THAT THE DEVICE WAS WORN FROM THE TIP. THIS REPORT IS FOR A 2.4MM STARDRIVE SCREWDRIVER SHAFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15959095 ↗
• MalfunctionDec 5, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, WHILE UTILIZING A BRAND NEW BROKEN SCREW REMOVAL SET, THE T8 MINI QUICK COUPLING SCREWDRIVER BROKE OFF INSIDE THE MINI QUICK COUPLING HANDLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A DELAY OF 15 MINUTES. THERE WERE NO PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 2.4MM STARDRIVE SCREWDRIVER SHAFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15915888 ↗
• MalfunctionNov 14, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, WHEN REVIEWING THE MATERIAL DURING AN ORTHOPEDIC PROCEDURE, IT WAS REALIZED THAT THE BLADE PART OF THE SCREWDRIVER WAS BROKEN IN ITS PROXIMAL PART. PATIENT AND PROCEDURE OUTCOMES WERE UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 2.4MM STARDRIVE SCREWDRIVER SHAFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15788517 ↗
• MalfunctionSep 27, 2022Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2022, THE SURGEON NOTED DRIVER TO BE STRIPPED AND POSSIBLY BROKEN ON ONE END. SURGERY WAS COMPLETED SUCCESSFULLY. NO FRAGMENTS WERE GENERATED. THIS REPORT INVOLVES ONE 2.4MM STARDRIVE SCREWDRIVER SHAFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15495323 ↗
• MalfunctionSep 14, 2022Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2022, THE SURGEON NOTED DRIVER TO BE STRIPPED AND POSSIBLY BROKEN ON ONE END. SURGERY WAS COMPLETED SUCCESSFULLY. NO FRAGMENTS WERE GENERATED. THIS REPORT INVOLVES ONE 2.4MM STARDRIVE SCREWDRIVER SHAFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15419659 ↗
• MalfunctionJul 25, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, THE SURGEON BROKE A SCREWDRIVER IN THE SCREWDRIVER HANDLE. THERE WERE NO FRAGMENTS RETAINED IN THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE (1) 2.4MM STARDRIVE SCREWDRIVER SHAFT. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15093857 ↗