NA 03.100.039Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982070883), received between Mar 30, 2017 and Nov 21, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 21, 2023Break; Failure to Cut; Break; Failure to Cut

  IT WAS REPORTED THAT DURING A PROCEDURE ON OCTOBER 30, 2023, TWO OSTEOTOMES SEEMED TO BE DULL AND HAD SMALL CHIPPING BETWEEN THEM. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO REPORTED DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A CURVED PELVIC OSTEOTOME 20MM WIDTH. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18185262 ↗
• 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 20MM WIDTH THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17090936 ↗
• MalfunctionOct 23, 2020Corroded; Corroded

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE CURVED PELVIC OSTEOTOME 15 MM AND 20 MM 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 20 MM WIDTH. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10727919 ↗
• 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 CURVED PELVIC OSTEOTOMY CHISEL. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8951664 ↗
• MalfunctionMar 30, 2017Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT DURING A PERIACETABULAR OSTEOTOMY (PAO) ON (B)(6) 2017 TO TREAT AN UNKNOWN CONDITION, THE WOODEN HANDLE OF THE CURVED OSTEOTOME INSTRUMENT BROKE FROM THE METAL PORTION OF THE DEVICE. THE FRAGMENTS WERE RETRIEVED, NO ADDITIONAL INTERVENTION REQUIRED. A SIMILAR INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. NO SURGICAL DELAY WAS REPORTED. NO HARM WAS REPORTED TO THE PATIENT. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH THE PATIENT IN STABLE CONDITION. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6445722 ↗