NA 03.000.395Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982065995), received between Feb 9, 2018 and Mar 3, 2026 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2026Material Fragmentation

  IT WAS REPORTED THAT THE THREE (X3) CUTTER DEVICES WERE HAVING PROBLEMS. IT WAS REPORTED THAT THE THREE SAW BLADES CAME WITH BROKEN WASHERS. 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. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. THIS IS REPORT 1 OF 3 FOR THE SAME EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24497863 ↗
• MalfunctionMar 3, 2026Material Fragmentation; Dull, Blunt

  THIS IS REPORT 1 OF 5 (B)(4). IT WAS REPORTED THAT THE CRESCENTIC BLADE DEVICE HAD BROKEN WASHERS AND THERE WERE FIVE BLADES EITHER DULL OR HAD BROKEN TEETH. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24495874 ↗
• MalfunctionAug 11, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED BY BELGIUM THAT DURING A TIBIA OSTEOTOMY VETERINARY SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE CUTTER DEVICE SAW BLADE BROKE. IT WAS REPORTED THAT THE SAW WAS USED APPROXIMATELY FIFTEEN TIMES MAXIMUM. IT WAS FURTHER REPORTED THAT A FRAGMENT OF BONE, ABOUT TWO TO THREE CENTIMETERS SHATTERED, WAS CRUSHED AND REPLACED IN THE LOCATION OF THE SHARD UNDER THE PLATE. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS NO HUMAN PATIENT INVOLVEMENT AS THIS WAS A VETERINARY PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17507890 ↗
• MalfunctionAug 31, 2018Fracture; Fracture

  IT WAS REPORTED FROM (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE CUTTER DEVICE BROKE EASILY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE OR WHETHER A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7838499 ↗
• MalfunctionFeb 9, 2018Fracture; Fracture

  IT WAS REPORTED FROM (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE BLADE DEVICE BROKE EASILY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. THERE WAS PATIENT INVOLVEMENT REPORTED. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7261725 ↗