NA 5300020509Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613153000969), received between Dec 16, 2019 and Dec 16, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionDec 16, 2019Fracture; Fracture

  IT WAS REPORTED THAT PRIOR TO A SURGICAL PROCEDURE, THE BUR BROKE AND EXITED THE ATTACHMENT. IT WAS ALSO REPORTED THAT THE EVENT CAUSED A 60 SECOND DELAY. IT WAS FURTHER REPORTED THAT NO ADVERSE CONSEQUENCES OCCURRED 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 9475397 ↗
• MalfunctionDec 16, 2019Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE BUR BROKE AND HIT A HEALTHCARE STAFF IN THE FACE WITH NO ADVERSE CONSEQUENCES. IT WAS FURTHER REPORTED THAT THE EVENT CAUSED A TWO MINUTE DELAY. IT WAS ALSO REPORTED THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT WAS SUBSEQUENTLY REPORTED THAT THE PROCEDURE WAS A TRIPLE ARTHRODESIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9475370 ↗