NA 357.406Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10886982196293), received between Sep 4, 2018 and Dec 15, 2022 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 15, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022, THAT (TFN FLEXIBLE SCREWDRIVER) IS PRODUCING BLACK FLAKES DURING THE CLEANING AND STERILIZATION PROCESS. SPD RAN THE SCREWDRIVER THROUGH THE PROCESS OVER 10 TIMES TO SEE IF IT WOULD IMPROVE, IT DID NOT. ITEM PULLED FROM CIRCULATION AND THEY ARE USING 03.037.028 (TFNA FLEXIBLE SCREWDRIVER) INSTEAD. PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO. THIS REPORT IS FOR ONE (1) 5.0MM FLEXIBLE HEXAGONAL SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15990489 ↗
• MalfunctionApr 29, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE TFN FLEXIBLE SCREWDRIVER SHAFT CAN CAPTURE DEBRIS AND IS NO LONGER AVAILABLE. THERE WAS NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES ONE(1) DEVICE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14253122 ↗
• MalfunctionFeb 17, 2021Material Twisted/Bent

  ADDITIONAL EVENT INFORMATION: THE ISSUE WAS DISCOVERED DURING THE STERILIZATION PROCESS. THERE WAS NO PATIENT AND PROCEDURE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11337415 ↗
• MalfunctionApr 1, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT DURING AN UNKNOWN PROCEDURE IT WAS DISCOVERED THAT BROWN SCREWDRIVER HANDLE IS STAINING. THERE WAS NO REPORTED DELAY. NO FRAGMENTS GENERATED AND PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS IS REPORT 7 OF 7 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9911166 ↗
• MalfunctionApr 1, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT DURING AN UNKNOWN PROCEDURE IT WAS DISCOVERED THAT BROWN SCREWDRIVER HANDLE IS STAINING. THERE WAS NO REPORTED DELAY. NO FRAGMENTS GENERATED AND PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS IS REPORT 3 OF 7 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9911157 ↗
• MalfunctionApr 1, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT DURING AN UNKNOWN PROCEDURE IT WAS DISCOVERED THAT BROWN SCREWDRIVER HANDLE IS STAINING. THERE WAS NO REPORTED DELAY. NO FRAGMENTS GENERATED AND PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS IS REPORT 4 OF 7 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9911156 ↗
• MalfunctionApr 1, 2020Device Reprocessing Problem; Device Reprocessing Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT DURING AN UNKNOWN PROCEDURE IT WAS DISCOVERED THAT BROWN SCREWDRIVER HANDLE IS STAINING. THERE WAS NO REPORTED DELAY. NO FRAGMENTS GENERATED AND PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9910536 ↗
• MalfunctionJan 10, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, A FLEXIBLE HEXAGONAL SCREWDRIVER BROKE DURING A LEFT TROCHANTERIC FIXATION NAIL (TFN) SURGERY. NO FRAGMENTS WERE GENERATED. A BACKUP DEVICE WAS AVAILABLE. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO PATIENT IMPACT. THIS REPORT IS FOR A 5.0MM FLEXIBLE HEXAGONAL SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8236579 ↗
• MalfunctionSep 4, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, THE FLEXIBLE HEXAGONAL SCREWDRIVER IN THE TROCHANTERIC FIXATION NAIL SET BROKE WHILE TRYING TO UNSCREW AN INTERNAL LOCKING MECHANISM. IT WAS UNKNOWN IF THERE WERE PATIENT AND PROCEDURE INVOLVED. THIS REPORT IS FOR A 5.0MM FLEXIBLE HEXAGONAL SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7841944 ↗
• MalfunctionSep 4, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem

  CANADA REPORTS THAT ON AN UNKNOWN DATE, THE SCREWDRIVER PLACED ON A TRAY WAS NOTED TO HAVE A GREASE-LIKE SUBSTANCE. IT WAS REPORTED THAT NO OTHER EXPLANATION CAN BE ASCERTAINED OTHER THAN THE GREASY SUBSTANCE COULD HAVE DERIVED FROM THE SCREWDRIVER. IT IS UNKNOWN IF THERE IS A SURGICAL OR A PATIENT INVOLVEMENT. THIS REPORT IS FOR A 5.0MM FLEXIBLE HEXAGONAL SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7841923 ↗