BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL HIGH TORQUE DRILL

    MDR report key: 2994283 · Received March 8, 2013

    Report

    Report Number
    0001811755-2013-00466
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 11, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS OVERHEATING DURING TESTING BY A FIELD SERVICE TECHNICIAN. UPON EVALUATION, IT WAS OBSERVED THAT THE DEVICE WOULD OPERATE AUTOMATICALLY WITHOUT USER ACTIVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100174 UNIVERSAL HIGH TORQUE DRILL DRILL, SURGICAL, ENT ERL STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1