N/A (REF 2296-3-125)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885825012519), received between Nov 24, 2020 and Nov 24, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 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.

• InjuryNov 24, 2020Break; Break

  IT WAS REPORTED THAT DURING A RIGHT TOTAL KNEE ARTHROPLASTY, A PORTION OF THE MICRO SAW BLADE BROKE WHILE IN USE. AN X-RAY WAS PERFORMED AT THE END OF THE CASE TO ENSURE THERE WERE NO REMAINING FRAGMENTS LEFT IN THE PATIENT. THE PIECE WAS LOCATED. NO FURTHER ISSUES REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10892109 ↗