Brasseler USA 5009093M0Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887919507611), received between Nov 15, 2023 and Nov 15, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 15, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  SCRUB TECH AND CIRC NURSE CONFIRMED THE BLADE(S) LOADED AND LOCKED INTO THE STRYKER SAW PROPERLY AS USUAL, NO ISSUES. THE BLADE WAS THEN USED TO CUT THE PATELLA BONE WITH NO ISSUES. IT WAS WHEN THE SURGEON ATTEMPTED TO CUT THE TIBIA BONE THAT THE BLADE BROKE. SCRUB TECH MENTIONED THAT AT ONE POINT THE BLADE STOPPED MOVING THOUGH SHE COULD HEAR THE SAW ENGAGING WHEN THE TRIGGER WAS PULLED. THEN SHORTLY AFTER, BLADE BROKE AT THE CRESCENT PORTION OF THE HUB. CHANGED SAW AND USED ANOTHER ONE OF THESE BLADES, AND THE SAME OCCURRED. NO PORTIONS OF THE BLADE FELL INTO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18144387 ↗