NA 511.912SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982238207), received between Dec 15, 2017 and Dec 15, 2017 — classified as 1 injury.

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. 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.

• InjuryDec 15, 2017Fracture; Material Separation; Fracture; Material Separation

  IT WAS REPORTED FROM (B)(6) THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA) SURGICAL PROCEDURE FOR KNEE OSTEOARTHRITIS IT WAS OBSERVED THAT THE TIP OF THE SAW BLADE DEVICE BROKE. IT WAS REPORTED THAT THERE WAS NO DELAY IN THE PROCEDURE DUE TO THE EVENT. IT WAS NOT REPORTED IF THERE WAS A SPARE DEVICE AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT REPORTED. IT WAS REPORTED THAT NOTHING WRONG WAS FOUND WITH X-RAY IMAGING, BUT A POSSIBILITY OF BROKEN PARTS BEING LEFT IN THE BODY COULD NOT BE DENIED. THE EXACT DATE OF THE EVENT WAS NOT REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 7123557 ↗