NA 03.000.390Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982065940), received between Sep 16, 2024 and Apr 30, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (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 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.

• MalfunctionApr 30, 2025Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT DURING A TIBIAL-PLATEAU-LEVELING OSTEOTOMY SURGICAL PROCEDURE FOR ANTERIOR CRUCIATE LIGAMENT RUPTURE, IT WAS DISCOVERED THAT THE CRESCENTIC BLADE 12MM RADIUS/45MMX0.6MM DEVICE HAD POOR SHARPNESS. IT WAS REPORTED THAT THERE WAS A THIRTY-MINUTE DELAY TO THE SURGICAL PROCEDURE. THERE WAS NO HUMAN PATIENT INVOLVEMENT AS THE DEVICE WAS USED IN A VETERINARY PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21933097 ↗
• MalfunctionApr 1, 2025Material Fragmentation; Separation Problem; Material Fragmentation; Separation Problem

  IT WAS REPORTED THAT THE SAW ATTACHMENT DEVICE, WHEN CONNECTING THE ATTACHMENT AND SAW AND PROCEEDING WITH THE "LOCKING," A BREAKAGE OCCURRED AT THE END OF THE STAR DRIVE (THE PART THAT BEARS A LOT OF FORCE WHEN SECURING THE ATTACHMENT AND SAW). FRAGMENTS FROM THE BREAKAGE ARE LODGED IN THE ATTACHMENT, MAKING IT IMPOSSIBLE TO DETACH AND SEPARATE THE SAW. THE EXACT DATE OF THIS EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2025. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21741391 ↗
• MalfunctionSep 26, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING CLEANING OF THE UNKNOWN SAW BLADE DEVICE, IT WAS FOUND TO HAVE FALLEN APART. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THIS EVENT IS UNKNOWN. THERE WAS NO HUMAN PATIENT INVOLVEMENT AS THE FACILITY IS A VETERINARY MEDICAL HOSPITAL, AND THEREFORE, THE DEVICE IS MOST LIKELY USED FOR VETERINARY PURPOSES ONLY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20309085 ↗
• MalfunctionSep 16, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED FROM THE SALES REP THAT PRIOR TO SURGERY, IT WAS OBSERVED THAT THE CRESCENTIC BLADE 12MM RADIUS DEVICE WAS CRACKED NEAR THE TOP. THERE WAS NO PATIENT INVOLVEMENT. THIS EVENT DID NOT OCCUR DURING SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20228899 ↗