NA 03.100.303Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982071293), received between Aug 30, 2019 and Apr 27, 2022 — classified as 2 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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 27, 2022Use of Device Problem; Contamination /Decontamination Problem; Use of Device Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE CUSTOMER IN (B)(6). THAT THE OSTEOTOME AND OSTEOTOME CHISEL DEVICES WERE IN TERRIBLE CONDITION. ACCORDING TO THE REPORT, THERE WERE CHUNKS OUT OF THE HANDLE THAT IT DID NOT GUARANTEE CLEANLINESS OR THAT FOREIGN MATTER WOULD NOT COME OFF DURING PROCEDURE. IT WAS FURTHER REPORTED THAT THERE WAS A MISSING SILVER STUD TO ATTACH THE METAL HEAD WHICH WAS POTENTIAL FOR DEBRIS AND BLOOD TO ACCUMULATE INSIDE. IT WAS REPORTED THAT THERE WAS A PROTRUDING SILVER STUD ON THE HANDLE WHICH WOULD BE A POTENTIAL FOR HOLE IN GLOVE, SKIN TEAR. IT WAS REPORTED THAT WHERE THE ¿WOODLIKE¿ HANDLE ATTACHED TO THE METAL KNOB ON THE BOTTOM OF THE HANDLE HAD A GAP THAT COULD HARBOUR DEBRIS, BLOOD ETC. IT WAS REPORTED THAT THERE WAS RED DISCOLOURATION/STAINING NOTED ON HANDLES AFTER WASH AND STERILISATION. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) PELVIC OSTEOTOME ANGL 20 DEVICE. THIS COMPLAINT INVOLVES 2 DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14222036 ↗
• 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 AN ANGLED PELVIC OSTEOTOMES. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8951703 ↗