BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN MIS BUR PRODUCT

    MDR report key: 2223261 · Received August 16, 2011

    Report

    Report Number
    9616696-2011-00138
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 19, 2011
    Manufacturer
    STRYKER IRELAND LTD.
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE BUR SUBJECT TO THIS INVESTIGATION WAS RETURNED TO THE MANUFACTURER FOR EVALUATION, IT WAS VISUALLY CONFIRMED THE HEAD OF THE BUR WAS BROKEN FROM THE SHANK. LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED TO PERMIT FURTHER INVESTIGATION. THE ROOT CAUSE IS UNDETERMINED. THE ATTACHMENT ASSOCIATED WITH THIS MDR IS AS FOLLOWS; PART NUMBER; 5100120952.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BUR WAS BROKEN INSIDE THE ATTACHMENT. IT WAS ALSO REPORTED THAT THIS EVENT OCCURRED AFTER THE SURGICAL PROCEDURE, AND THERE WAS NO PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN MIS BUR PRODUCT HBE STRYKER IRELAND LTD. 09287

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK