NA 314.57Recalls & reported problems

Summary

The FDA's MAUDE database contains 74 adverse event reports that list this exact device (DI 10886982188984), received between Oct 24, 2017 and Jul 28, 2026 — classified as 2 injuries, 72 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (42 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 74 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 28, 2026Device-Device Incompatibility; Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50057466 ↗
• MalfunctionApr 23, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE END OF THE DRIVER WAS ROUNDED OFF. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21896035 ↗
• MalfunctionFeb 26, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT THE INSTRUMENTS WERE BROKEN INTRAOPERATIVELY AND SCREWDRIVER RECESS WAS STRIPPED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH PATIENT OUTCOME IS REPORTED AS OKAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21471437 ↗
• MalfunctionNov 27, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING SURGERY ON AN UNKNOWN DATE, THE END OF THE SCREWDRIVER WAS ROUNDED. THERE WAS NO PATIENT CONSEQUENCE. SURGICAL DELAY WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20795220 ↗
• MalfunctionNov 26, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE WOODEN HANDLE BROKE. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20787612 ↗
• MalfunctionNov 18, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED, THAT ON AN UNKNOWN DATE. THE END OF THE HEX DRIVER WAS ROUNDED. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20714029 ↗
• MalfunctionAug 12, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT DURING FIELD INSPECTION/PROCESSING, IT WAS DISCOVERED THAT THE SCREWDRIVER HANDLES ARE LEAVING A STAIN ON THE PEEL PACKS. THERE WERE NO PATIENT INVOLVEMENT, THIS REPORT IS FOR ONE (1) SMALL HEXAGONAL SCREWDRIVER LONG. THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19968064 ↗
• MalfunctionApr 25, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE INSTRUMENTS WERE BROKEN. THIS REPORT INVOLVES ONE (1) SMALL HEXAGONAL SCREWDRIVER LONG. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19181226 ↗
• MalfunctionJan 16, 2024Break; Break

  THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18522268 ↗
• MalfunctionJan 9, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT IN (B)(6) 2023, AFTER VISUAL EXAMINATION, THE DEVICES WERE FOUND TO HAVE THE FOLLOWING CONDITIONS: BENT, BROKEN, AND/OR STRIPPED. THIS REPORT INVOLVES ONE (1) SMALL HEXAGONAL SCREWDRIVER LONG. THIS IS REPORT 1 OF 7 FOR (B)(4)..

  Patient problems: Insufficient Information

  MAUDE report 18474095 ↗
• MalfunctionDec 21, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2023, THE HEX HAS ROUNDED AT THE END. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) SMALL HEXAGONAL SCREWDRIVER LONG THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18371822 ↗
• MalfunctionSep 28, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2023, BOTH THE 2.5 HEX POWER SCREWDRIVER AND 2.5 HEX HAND HELD SCREWDRIVER HEADS STRIPPED WHILE PUTTING IN SCREWS. NO FRAGMENTS WERE GENERATED. THERE WERE NO REPORTED PATIENT CONSEQUENCES AND NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A SCRDRIVER-HEX-SMALL Ø2.5 L270. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17833701 ↗
• MalfunctionSep 11, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, ALL SCREWDRIVERS WERE STRIPPED AND WOULD NOT RETAIN TO SCREWS. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE SMALL HEXAGONAL SCREWDRIVER LONG. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17719255 ↗
• MalfunctionSep 11, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, ALL SCREWDRIVERS WERE STRIPPED AND WOULD NOT RETAIN TO SCREWS. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE SMALL HEXAGONAL SCREWDRIVER LONG. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17719254 ↗
• MalfunctionSep 11, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, ALL SCREWDRIVERS WERE STRIPPED AND WOULD NOT RETAIN TO SCREWS. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE SMALL HEXAGONAL SCREWDRIVER LONG. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17719252 ↗
• MalfunctionAug 14, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE END OF THE HEX DRIVER BROKE OFF INTO THE SCREW. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE SMALL HEXAGONAL SCREWDRIVER LONG. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17542156 ↗
• MalfunctionAug 14, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE END OF THE HEX DRIVER BROKE OFF INTO THE SCREW. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE SMALL HEXAGONAL SCREWDRIVER LONG. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17541269 ↗
• MalfunctionJul 12, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE END OF THE HEX WAS ROUNDED. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE SMALL HEXAGONAL SCREWDRIVER LONG. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17304698 ↗
• MalfunctionJul 6, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE HEX DRIVER IS ROUNDED AT THE END. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME WAS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) SMALL HEXAGONAL SCREWDRIVER LONG THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17266231 ↗
• MalfunctionMay 3, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE HEX AT THE END OF THE SCREWDRIVER HAD ROUNDED. THERE WAS NO PATIENT CONSEQUENCE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE SMALL HEXAGONAL SCREWDRIVER LONG. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16860133 ↗
• MalfunctionFeb 2, 2023Material Twisted/Bent; Material Twisted/Bent

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16287334 ↗
• MalfunctionFeb 2, 2023Material Twisted/Bent; Material Twisted/Bent

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16287031 ↗
• MalfunctionSep 30, 2022Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SCREWDRIVER TIP BROKE. STRIKING CAP ALSO BROKE. THE THREADED TIP OF THE HAMMER GUIDE BROKE INSIDE OF THE BLOCK. WE ENDED UP MALLETING THE HANDLE TO COMPLETE THE SURGERY. NO FRAGMENTS GENERATED OR ADDITIONAL INTERVENTION. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) SCRDRIVER-HEX-SMALL Ø2.5 L270 THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15510287 ↗
• MalfunctionAug 30, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM THE UNITED KINGDOM REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022, THE NEW SCREWDRIVER AND SCREWDRIVER SHAFT WOULD NOT ENGAGE WITH THE SCREW RECESS DURING INSERTION. THERE WAS A 5-10 MINUTE DELAY WHILE A NEW INSTRUMENT WAS OPENED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A SMALL HEXAGONAL SCREWDRIVER LONG. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15320811 ↗
• MalfunctionJun 7, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2022, WHILE INSPECTING THE INSTRUMENTS AFTER COMING OUT OF THE DECONTAMINATION PROCESS, THERE WERE A FEW ITEMS THAT WERE DAMAGED. THE SMALL HEXAGONAL SCRDRIVER HOLDING SLV IS STRIPPED, THE SCREWDRIVER, HEXAGONAL, SMALL, Ø 2.5 MM, LENGTH 270 MM IS BROKEN HALF WAY DOWN THE SHAFT OF THE SCREWDRIVER, THE OTHER SCREWDRIVER, HEXAGONAL, SMALL, Ø 2.5 MM, LENGTH 270 MM IS STRIPPED, AND THE HELICAL BLADE/SCREW COUPLING SCREW THREADS ARE STRIPPED AND SMASHED TOGETHER AND CANNOT BE USED. THIS REPORT INVOLVES ONE (1) SMALL HEXAGONAL SCREWDRIVER LONG. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14622751 ↗