BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN MIS BUR

    MDR report key: 2820474 · Received November 1, 2012

    Report

    Report Number
    9616696-2012-00282
    Event Type
    Malfunction
    Date Received
    November 1, 2012
    Date of Event
    October 5, 2012
    Report Date
    October 5, 2012
    Manufacturer
    STRYKER IRELAND LTD.
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE BUR AND ATTACHMENT SUBJECT TO THIS INVESTIGATION WAS RETURNED FOR EVALUATION. IT WAS VISUALLY CONFIRMED THAT THE BUR WAS BROKEN ALONG THE SHANK. THE RETURNED BUR WAS MEASURED WHERE POSSIBLE AND ALL CRITICAL SPECIFICATIONS WERE MET. PART NUMBER AND LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED TO PERMIT FURTHER INVESTIGATION. THE ROOT CAUSE IS MULTI-FACTORIAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING CONDUCTED AT THE MANUFACTURER THAT THE BUR WAS BROKEN INSIDE THE HANDPIECE. IT WAS ALSO REPORTED THAT WAS NO DELAY AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN MIS BUR HBE STRYKER IRELAND LTD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK LOT NUMBER: 11266| ATTACHMENT PART NUMBER: 5100120922