BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO DRILL MEDIUM STRAIGHT ATTACHMENT

    MDR report key: 2891104 · Received November 14, 2012

    Report

    Report Number
    1811755-2012-04052
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 12, 2012
    Report Date
    October 12, 2012
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S COMPLAINT WAS CONFIRMED; AN UNK BUR WAS STUCK IN THE ATTACHMENT. THE BURR DID NOT HAVE A J NOTCH WHICH IS ACCEPTED BY THIS ATTACHMENT AND RECOMMENDED IN THE IFU. THE STRYKER IFU ALSO RECOMMENDS THE USE OF ONLY STRYKER APPROVED COMPONENTS AND ACCESSORIES AS THE ATTACHMENT MAY CAUSE A NON-STRYKER BUR TO BREAK AND IF THE WRONG TYPE OF BUR IS USED.

    Description of Event or Problem · 1

    A MICRO DRILL MEDIUM STRAIGHT ATTACHMENT WAS SENT FOR SERVICE BECAUSE SOMETHING WAS STUCK IN IT. DURING EVAL OF THE DEVICE, AN UNK BROKEN BURR WAS NOTED IN THE ATTACHMENT. NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO DRILL MEDIUM STRAIGHT ATTACHMENT ERL STRYKER INSTRUMENTS KALAMAZOO 11131

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK