NA 532.095SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982241160), received between Dec 22, 2017 and Dec 22, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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 16, 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.

• MalfunctionDec 22, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED THAT DURING AN ULNAR OSTEOTOMY SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE SAW BLADE DEVICE WOULD NOT FIT ON THE ATTACHMENT AND THE WIRE DEVICE BROKE INTO TWO PIECES (BOTH DEVICES WERE BEING USED TOGETHER DURING THE SAME PROCEDURE. IT WAS REPORTED THAT THERE WAS A 10 MINUTE DELAY IN SURGERY IN ORDER TO OBTAIN A SAW BLADE THAT WOULD FIT IN THE ATTACHMENT. IT WAS REPORTED THAT BOTH PIECES OF THE WIRE WERE EASILY REMOVED. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED WITH NO FURTHER ISSUES. 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 7142285 ↗