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NA 1608002055Recalls & reported problems

Stryker Corporation · 4.0mm Round Bur · Class 1

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540030658), received between Apr 17, 2019 and Apr 17, 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Break1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 17, 2019Break; Break

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE ON THE HAND, THE BUR BROKE AT THE NOTCH END. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND NO DELAYS 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 8522911 ↗

Other BUR, SURGICAL, GENERAL & PLASTIC SURGERY devices

All BUR, SURGICAL, GENERAL & PLASTIC SURGERY devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.