NA 5820017050Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540374363), received between Nov 6, 2019 and Nov 6, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 6, 2019Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE BUR BROKE, THE FRAGMENT WAS EXPELLED IN THE OPERATING ROOM AND THE REMAINDER OF THE BUR STAYED STUCK IN THE ASSOCIATED HANDPIECE DRILL. IT WAS ALSO REPORTED THAT A REPLACEMENT DRILL AND A NEW BUR WAS USED TO COMPLETE THE SURGERY ALSO BROKE DURING THE PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR THE SECOND BUR THAT BROKE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9284410 ↗
• MalfunctionNov 6, 2019Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE BUR BROKE, THE FRAGMENT WAS EXPELLED IN THE OPERATING ROOM AND THE REMAINDER OF THE BUR STAYED STUCK IN THE ASSOCIATED HANDPIECE DRILL. IT WAS ALSO REPORTED THAT A REPLACEMENT DRILL AND A NEW BUR WAS USED TO COMPLETE THE SURGERY ALSO BROKE DURING THE PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR THE FIRST BUR THAT BROKE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9284406 ↗