NA 03.100.038Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982070876), received between Apr 26, 2018 and Jun 8, 2023 — classified as 1 injury, 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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 8, 2023Break; Failure to Cut; Break; Failure to Cut

  IT WAS REPORTED THAT ON UNKNOWN DATE, THIS IS T BY 5.3 INVOLVING TWO PIECES EXERTION OF CURVED PELVIC OSTEOTOME 20MM WIDTH & CURVED PELVIC OSTEOTOME 15MM WIDTH. THESE ITEMS ARE DULL AND CHIPPED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS COMPLAIN INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) CURVED PELVIC OSTEOTOME 15MM WIDTH. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17090785 ↗
• MalfunctionJan 6, 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) CURVED PELVIC OSTEOTOME 15MM WIDTH THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16111912 ↗
• MalfunctionOct 23, 2020Corroded; Corroded

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE CURVED PELVIC OSTEOTOME 15MM AND 20MM WIDTH WERE PITTING ON THE EDGE OF THE BLADE DURING THE INSPECTION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) CURVED PELVIC OSTEOTOME 15MM WIDTH. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10727877 ↗
• InjuryApr 26, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED A PERIACETABULAR OSTEOTOMY (PAO) PROCEDURE WAS BEING PERFORMED ON (B)(6) 2018. DURING THE PROCEDURE THE SURGEON NOTICED THE HANDLE NO LONGER ALIGNED PROPERLY WITH THE BLADE OF THE CHISEL. UPON FURTHER INSPECTION IT BECAME CLEAR THAT THE WOODEN HANDLE WAS NO LONGER ATTACHED TO THE METAL SHANK. ANOTHER OSTEOTOME WAS USED TO COMPLETE THE PROCEDURE. THERE WAS MINIMAL SURGICAL DELAY, MAYBE A MINUTE OR TWO. PATIENT STATUS WAS REPORTED AS STABLE WITH NO ILL EFFECT AND PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7464744 ↗