NA 03.000.392Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982065964), received between Feb 22, 2019 and Mar 2, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Dull, Blunt” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2026Dull, Blunt

  IT WAS REPORTED THAT THE TIBIAL-PLATEAU-LEVELING OSTEOTOMY (TPLO) BLADE DEVICE WAS NOT CUTTING WELL. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN A SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS NOT REPORTED; HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24478949 ↗
• MalfunctionJun 12, 2020Material Fragmentation; Material Fragmentation

  IT WAS REPORTED FROM (B)(6) THAT DURING AN ORTHOPEDIC TIBIAL PLATEAU LEVELING OSTEOTOMY VETERINARY PROCEDURE, IT WAS OBSERVED THAT THERE WAS BREAKAGE ON THE BLADE DEVICE. IT WAS REPORTED THAT THERE WAS AN UNSPECIFIED AMOUNT OF DELAY TO THE SURGICAL PROCEDURE. IT WAS FURTHER REPORTED THAT A SPARE BLADE DEVICE WAS AVAILABLE FOR USE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. 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 WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10148748 ↗
• MalfunctionFeb 22, 2019Fracture; Fracture

  IT WAS REPORTED FROM (B)(6) THAT AT THE CONCLUSION OF AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE CUTTER DEVICE BROKE. ACCORDING TO THE REPORTER, ALL FRAGMENTS WERE REMOVED FROM THE PATIENT AND THE CUTTING WAS COMPLETED NORMALLY. IT AS REPORTED THAT THERE WAS A DELAY IN THE PROCEDURE, HOWEVER IT WAS NEGLIGIBLE DUE TO THE EVENT OCCURRING AT THE END OF THE PROCEDURE. A SPARE DEVICE WAS NOT NEEDED SINCE THE PROCEDURE WAS COMPLETED. 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 8363777 ↗