BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN MIS BUR

    MDR report key: 2864439 · Received December 5, 2012

    Report

    Report Number
    9616696-2012-00314
    Event Type
    Malfunction
    Date Received
    December 5, 2012
    Date of Event
    November 7, 2012
    Report Date
    November 7, 2012
    Manufacturer
    STRYKER IRELAND LTD., INSTRUMENTS DIVISION
    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 EVAL. 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 INFO HAS NOT BEEN PROVIDED TO PERMIT FURTHER INVESTIGATION. THE ROOT CAUSE IS MULTI-FACTORIAL.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA THE CUSTOMER THAT THE BUR WOULD NOT FIT IN THE ATTACHMENT. IT WAS SUBSEQUENTLY REPORTED THAT DURING TESTING CONDUCTED AT THE MFR THAT THE BUR WAS BROKEN INSIDE THE ATTACHMENT. IT WAS ALSO REPORTED THAT THIS EVENT DID NOT OCCUR DURING A 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 HBE STRYKER IRELAND LTD., INSTRUMENTS DIVISION UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ATTACHMENT PART #: 5100120922, LOT #: 11339