NA 399.86Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982203120), received between Oct 22, 2021 and Jun 10, 2024 — classified as 3 malfunctions.

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

• MalfunctionJun 10, 2024Use of Device Problem; Failure to Cut; Use of Device Problem; Failure to Cut

  IT WAS REPORTED THAT ON 18 MARCH 2024, THE CUSTOMER CALLED REGARDING A CHISEL WITH A BLUE PLASTIC HANDLE ON TOP OF THE METAL HANDLE. THE PLASTIC IS PRINTED WITH TWO METAL PLUGS, ONE OF WHICH IS GONE AND THE OTHER IS ON ITS WAY OUT. ANOTHER NURSE ALSO MENTIONED THAT THE CHISEL WAS DULL. THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO SURGICAL DELAY. UPON EVALUATION OF THE DEVICE ON 5-JUNE-2024, IT WAS NOTED THAT THE DEVICE WAS STRIPPED, AND WAS ALSO REFURBISHED AND POSSIBLY MODIFIED BY A THIRD PARTY COMPANY. THIS REPORT INVOLVES ONE PELVIC OSTEOTOME 20MM/304MM . THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19498240 ↗
• MalfunctionJan 5, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2022, UPON REVIEW IT WAS DISCOVERED THAT THE TIPS OF THE OSTEO CHISEL BLADE WERE BENT AND DENTED. NO SURGICAL DELAY WAS REPORTED AND NO PATIENT CONSEQUENCES. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) PELVOSTEOT-CHISEL W/20 L304/134. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16109700 ↗
• MalfunctionOct 22, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE HANDLE IS LEAVING A BROWN RESIDUE ON THE PEEL PACK AFTER STERILIZATION. THERE WAS NO PATIENT INVOLVEMENT. THE ISSUE WAS AN INTERNAL PROCESS FOR THEIR PEEL PACKING PROCEDURES. THIS REPORT IS FOR ONE (1) PELVIC OSTEOTOME 20MM/304MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12681989 ↗