BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPACTION DRILL SHIELD

    MDR report key: 2200935 · Received July 1, 2011

    Report

    Report Number
    1811755-2011-02393
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 7, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED FOR EVAL; ADDITIONAL INFO WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETED. PLEASE NOTE THAT THE LOT NUMBER FOR THE DEVICE IS UNK; AS A RESULT IT IS NOT POSSIBLE TO DETERMINE THE MFG DATE OF THE DEVICE.

    Description of Event or Problem · 1

    A CORE IMPACTION DRILL WAS SENT IN FOR SERVICE AND A MELTED IMPACTION DRILL SHIELD WAS NOTED ON THE HANDPIECE. NO ADVERSE EVENT WAS ASSOCIATED WITH THE IMPACTION DRILL SHIELD; NO FURTHER INFO IS AVAILABLE REGARDING THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPACTION DRILL SHIELD DZJ STRYKER INSTRUMENTS KALAMAZOO UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK