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NA 1608002011Recalls & reported problems

Stryker Corporation · 3.2mm 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 04546540030504), received between Feb 19, 2019 and Feb 19, 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.

  • MalfunctionFeb 19, 2019Break; Break

    IT WAS REPORTED THAT DURING A SPORTS MEDICINE SURGICAL PROCEDURE, THE BUR BROKE AT THE NOTCH. IT WAS ALSO REPORTED THAT THE BUR FELL OUT OF THE ATTACHMENT. IT WAS FURTHER REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES OR SURGICAL DELAY DUE TO THIS EVENT. IT WAS ALSO REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8351650 ↗

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.