NA 397.70Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886982201058), received between Mar 24, 2017 and Dec 12, 2023 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE GAUGE PIECES NO LONGER SECURELY FIT INTO THE HANDLE. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE HANDLE FOR GOUGES & CHISELS QC. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18311258 ↗
• MalfunctionNov 4, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, THE ITEM WAS NOT PROPERLY HOLDING THE ATTACHMENTS. THERE WAS NO PATIENT OR OPERATION INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE HANDLE FOR GOUGES & CHISELS QC. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15730261 ↗
• MalfunctionDec 29, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE HAND WITH QUICK COUPLING WOOD HANDLE WAS SHEDDING WOOD FLAKE LIKE PIECES WHILE BEING STERILIZED WHICH IS CAUSING POTENTIAL CONTAMINATION ISSUES. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A HAND WITH QUICK COUPLING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13112480 ↗
• MalfunctionOct 22, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, THE HANDLE FOR GAUGES AND CHISELS, QUICK COUPLING WAS FOUND THAT THE INTERCHANGEABLE TAMP WOULD NO LONGER LOCK INTO THE HANDLE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) HANDLE FOR GOUGES & CHISELS QC. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12685483 ↗
• MalfunctionMar 26, 2021Break; Break

  IT WAS REPORTED THAT ON FEBRUARY 26, 2021, IT WAS FOUND IN STERILE PROCESSING TO HAVE A LARGE PIECE CUT OUT OF HANDLE WITH QUICK COUPLING. THERE WAS NO PROCEDURE AND PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1)HANDLE FOR GOUGES & CHISELS QC. THIS REPORT IS 1 OF 1 PC (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11577554 ↗
• MalfunctionOct 18, 2019Break; Break

  IT WAS REPORTED THAT DURING STERILE PROCESSING ON AN UNKNOWN DATE, THE BACK OF A HANDLE FOR GOUGES AND CHISELS WAS CHIPPING OFF AND THE WOOD PORTION WAS FLICKING OFF. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) HANDLE FOR GOUGES & CHISELS QC. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9209484 ↗
• MalfunctionSep 17, 2019Break; Break

  IT WAS REPORTED ON (B)(6) 2019, DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE TIBIA, IT WAS FOUND OUT THAT THE CHIPS OF THE STIMULATED WOOD OF THE TWO (2) HANDLE FOR GOUGES AND CHISELS HAD BEEN BULGED OUT OR BROKEN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. PATIENT OUTCOME IS EXCELLENT. THIS REPORT IS FOR ONE (1) HANDLE FOR GOUGES & CHISELS QC THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9077137 ↗
• MalfunctionSep 17, 2019Break; Break

  IT WAS REPORTED ON (B)(6) 2019, DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE TIBIA, IT WAS FOUND OUT THAT THE CHIPS OF THE STIMULATED WOOD OF THE TWO (2) HANDLE FOR GOUGES AND CHISELS HAD BEEN BULGED OUT OR BROKEN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. PATIENT OUTCOME IS EXCELLENT. THIS REPORT IS FOR ONE (1) HANDLE FOR GOUGES & CHISELS QC THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9077113 ↗
• MalfunctionMar 24, 2017Break; Break

  IT WAS REPORTED FOLLOWING STERILE PROCESSING THAT THE BROWN NYLON PORTION OF THE HANDLE OF THE CHISEL HAD A CHUNK OUT OF IT. NO PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6433213 ↗