PRECICE Osteotome Blade, 12mm BLD1-012Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887517006684), received between Apr 27, 2021 and Apr 27, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Material Deformation” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 27, 2021Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED THAT AFTER THE SURGEON PERFORMED AN OSTEOTOMY WITH THE 12MM BLADE, IT WAS DISCOVERED THAT THE CUTTING TIP OF THE BLADE HAD DEFORMED DURING IMPACTION. DURING CONFIRMATION OF A COMPLETED OSTEOTOMY, THE SURGEON NOTED A SMALL SPIRAL CRACK IN THE BONE HAD PROPAGATED FROM THE OSTEOTOMY SITE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Bone Fracture(s)

  MAUDE report 11731667 ↗