NA 399.85Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982203113), received between Apr 15, 2019 and Sep 13, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 13, 2023Break; Failure to Cut; Break; Failure to Cut

  IT WAS REPORTED THAT THE CUTTING BLADES OF THE OSTEOTOMES WERE DULLED AND/OR BROKEN. THERE WERE NO ADVERSE CONSEQUENCES, AS THEY WERE NOT PATIENT-RELATED ISSUES. THIS REPORT IS FOR ONE (1) PELVIC OSTEOTOME 15MM/304MM THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17737030 ↗
• MalfunctionAug 30, 2019Material Deformation; Material Deformation

  IT WAS REPORTED ON AUGUST 02, 2019, ONE (1) CURVED PELVIC OSTEOTOMY CHISEL, ONE (1) PELVIC OSTEOTOMY CHISELS, ONE (1) ANGLED PELVIC OSTEOTOMES AND ONE (1) BAYONET-SHAPED PELVIC OSTEOTOMES WERE NOTICED TO HAVE GOUGES AND FLATTENING OF THE CUTTING EDGES THROUGH INSPECTION. THERE WAS NO PATIENT AND PROCEDURE INVOLVEMENT. THIS REPORT IS FOR A PELVIC OSTEOTOMY CHISEL. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8951695 ↗
• MalfunctionApr 15, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT ON FEBRUARY 22, 2019, THE STERILE PROCESSING DEPARTMENT DISCOVERED THAT THE PELVIC OSTEOTOMY CHISEL HANDLE HAD LOOSENING HOLDING PINS. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) PELVIC OSTEOTOME 15MM/304MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8515552 ↗