NA 388.31Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705034772417), received between Jun 8, 2021 and May 9, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 9, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE WOOD HANDLED INSTRUMENTS WERE LEAVING A STAIN/RESIDUE WHEN THEY ARE PEELPACKED AND STERILIZED. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE (1) LONG SMALL HEXAGONAL SCREWDRIVER. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4). THIS COMPLAINT IS RELATED TO (B)(4) AND (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16899031 ↗
• MalfunctionMay 9, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE WOOD HANDLED INSTRUMENTS WERE LEAVING A STAIN/RESIDUE WHEN THEY ARE PEELPACKED AND STERILIZED. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE (1) LONG SMALL HEXAGONAL SCREWDRIVER. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4). THIS COMPLAINT IS RELATED TO (B)(4) AND (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16898844 ↗
• MalfunctionJun 8, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE HANDLE OF TWO SCREWDRIVERS WERE LEAVING RESIDUES IN THE PEEL PACK AFTER THE STERILIZATION PROCESS WAS COMPLETE. IT IS UNKNOWN IF THERE IS PATIENT/PROCEDURE INVOLVEMENT. THIS REPORT IS FOR A LONG SMALL HEXAGONAL SCREWDRIVER. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11959649 ↗
• MalfunctionJun 8, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE HANDLE OF TWO SCREWDRIVERS WERE LEAVING RESIDUES IN THE PEEL PACK AFTER THE STERILIZATION PROCESS WAS COMPLETE. IT IS UNKNOWN IF THERE IS PATIENT/PROCEDURE INVOLVEMENT. THIS REPORT IS FOR A LONG SMALL HEXAGONAL SCREWDRIVER. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11958317 ↗
• MalfunctionJun 8, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE HANDLE OF TWO SCREWDRIVERS WERE LEAVING RESIDUES IN THE PEEL PACK AFTER THE STERILIZATION PROCESS WAS COMPLETE. IT IS UNKNOWN IF THERE IS PATIENT/PROCEDURE INVOLVEMENT. THIS REPORT IS FOR A LONG SMALL HEXAGONAL SCREWDRIVER. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11958314 ↗