NA 05.003.126SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982131287), received between May 11, 2018 and May 11, 2018 — classified as 1 malfunction.

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

• MalfunctionMay 11, 2018Fracture; Fracture

  IT WAS REPORTED FROM (B)(6) THAT DURING A TOTAL KNEE ARTHROPLASTY SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE SAW BLADE WAS BROKEN. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE OR WHETHER A SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS REPORTED THAT THERE WERE NO BROKEN PARTS IN THE PATIENT'S BODY. 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 7508614 ↗