NA 03.111.017Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982072160), received between Sep 30, 2021 and Nov 8, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 8, 2022Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE CHISEL IN ORTHOPEDIC SET, DURING STERILIZATION DEPARTMENT, REPORTED TO BE BROKEN. IT WAS DISCARDED. IT WAS NOT USED TO PERFORM IN THE SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) JOINT PREP/CHISEL/20 DEG BEND NARROW 10. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15756093 ↗
• MalfunctionSep 30, 2021Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE, DURING INSPECTION IT WAS IDENTIFIED THAT THE JOINT PREP/CHISEL/20 DEG BEND NARROW 10 WAS DENTED. IT WAS NOTED THAT POSSIBLY UNSAFE TO USE. THIS REPORT IS FOR ONE (1) JOINT PREP/CHISEL/20 DEG BEND NARROW/10MM WIDE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12556199 ↗