P.F.C. 85-3927Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295207757), received between Jul 2, 2019 and Aug 18, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (6 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2025Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL HIP REPLACEMENT, AND THE RASP WAS CHIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22832830 ↗
• MalfunctionJun 6, 2024Failure to Cut; Failure to Cut

  DURING ROUTINE TOTAL HIP SURGERY, SURGEONS IDENTIFIED THAT THE INSTRUMENTS HAD BECOME DULL. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19480430 ↗
• MalfunctionJun 23, 2022Failure to Cut; Naturally Worn; Failure to Cut; Naturally Worn

  IT WAS REPORTED THAT THE CUTTING EDGE IS DULL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14791931 ↗
• MalfunctionJun 23, 2022Failure to Cut; Naturally Worn; Failure to Cut; Naturally Worn

  IT WAS REPORTED THAT THE CUTTING EDGE IS DULL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14791851 ↗
• MalfunctionJun 23, 2022Failure to Cut; Naturally Worn; Failure to Cut; Naturally Worn

  IT WAS REPORTED THAT THE CUTTING EDGE IS DULL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14791816 ↗
• MalfunctionJun 23, 2022Failure to Cut; Naturally Worn; Failure to Cut; Naturally Worn

  IT WAS REPORTED THAT THE CUTTING EDGE IS DULL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14791765 ↗
• MalfunctionMay 3, 2022Failure to Cut; Failure to Cut

  INSTRUMENT IS DULL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14269660 ↗
• MalfunctionOct 1, 2019Scratched Material; Scratched Material

  MDR HAS INDICATED 3X MEDIUM BOX OSTEOTOMES AND 3X RASPS HAVE SEVERAL DINGS / DENTS DUE TO WEAR AND TEAR AND NEED TO BE REPLACED. PRODUCTS ARE NO LONGER FUNCTIONAL AND REPLACEMENTS ARE REQUIRED. NOT INTRA-OP AND THEREFORE NO PATIENT ISSUES. NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. PLEASE SEND REPLACEMENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9141144 ↗
• MalfunctionOct 1, 2019Scratched Material; Scratched Material

  MDR HAS INDICATED 3X MEDIUM BOX OSTEOTOMES AND 3X RASPS HAVE SEVERAL DINGS / DENTS DUE TO WEAR AND TEAR AND NEED TO BE REPLACED. PRODUCTS ARE NO LONGER FUNCTIONAL AND REPLACEMENTS ARE REQUIRED. NOT INTRA-OP AND THEREFORE NO PATIENT ISSUES. NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. PLEASE SEND REPLACEMENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9141143 ↗
• MalfunctionOct 1, 2019Scratched Material; Scratched Material

  MDR HAS INDICATED 3X MEDIUM BOX OSTEOTOMES AND 3X RASPS HAVE SEVERAL DINGS/DENTS DUE TO WEAR AND TEAR AND NEED TO BE REPLACED. PRODUCTS ARE NO LONGER FUNCTIONAL AND REPLACEMENTS ARE REQUIRED. NOT INTRA-OP AND THEREFORE NO PATIENT ISSUES. NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. PLEASE SEND REPLACEMENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9141140 ↗
• MalfunctionJul 2, 2019Dull, Blunt; Dull, Blunt

  SURGEON HAS INDICATED LATERALIZING RASP ((B)(4)) PRODUCT IS DULL FROM WEAR AND TEAR (NOT SHARP ENOUGH TO PROPERLY REMOVE BONE). PRODUCT IS NO LONGER FUNCTIONAL AND REPLACEMENT IS REQUIRED. NO INTRA-OP OR PATIENT ISSUES. NO SURGICAL DELAY. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? --> NO. PATIENT STATUS/ OUTCOME / CONSEQUENCES --> NO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8753679 ↗