NA 1900015040Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327376319), received between Nov 6, 2019 and Nov 6, 2019 — classified as 1 malfunction.

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. 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 6, 2019Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING A FOOT/ANKLE PROCEDURE THE BUR BROKE AT THE CUTTING END. IT WAS FURTHER REPORTED THAT THERE WAS A DELAY OF LESS THAN 5 MINUTES TO OBTAIN AN ALTERNATIVE DEVICE. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9285965 ↗