NA 03.100.300Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982071262), received between Jul 9, 2020 and Dec 15, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 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.

• InjuryDec 15, 2025Break; Break

  IT WAS REPORTED THAT THE DEPUY SYNTHES HIP PRESERVATION TRAY WAS BEING USED DURING A PERIACETABULAR OSTEOTOMY SURGERY AND THE PIN IN THE HANDLE OF THE OSTEOTOME CAME LOOSE IN THE PATIENT. THE EVENT OCCURED INTRA-OP, NOTICED POST-OP, AND THEREFORE THE PATIENT HAD TO HAVE A SECOND SURGERY TO REMOVE THE PIN.

  Patient problems: Insufficient Information

  MAUDE report 23810896 ↗
• 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) STRAIGHT PELVIC OSTEOTOME 15MM. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17737109 ↗
• MalfunctionSep 17, 2020Defective Component; Defective Component

  DEVICE REPORT FROM PORTUGAL REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE UNDERWENT FOR PELVIC RING SURGERY. DURING THE SURGERY, WHEN USING THE INSTRUMENT TO PERFORM AN OSTEOTOMY, THE STEEL SUFFERED WITH THE DAMAGE. IT WAS UNKNOWN IF THE SURGERY COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) STRAIGHT PELVIC OSTEOTOME 15MM. THIS IS REPORT 1 OF 1 (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10547142 ↗
• MalfunctionJul 9, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING AN INSPECTION IT WAS NOTICED THAT ONE (1) STARDRIVE SCREWDRIVER'S END WAS PITTED, AND ONE (1) STRAIGHT PELVIC OSTEOTOME'S BLADE ON THE END WAS PITTED. THERE WAS NO PATIENT INVOLVEMENT. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICES IT WAS OBSERVED THAT THE EDGES OF DISTAL TIP OF THE DEVICE WAS FOUND TO BE DEFORMED/BENT. THIS DEVICE CONDITION WAS REASSESSED AND DETERMINED TO BE REPORTABLE ON JULY 1, 2020. THIS REPORT IS FOR ONE (1) STRAIGHT PELVIC OSTEOTOME 15MM. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10254867 ↗