BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL DRILL

    MDR report key: 2233177 · Received July 22, 2011

    Report

    Report Number
    1811755-2011-02625
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 28, 2011
    Report Date
    July 5, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DRILL WAS REC'D AT THE MFR FOR EVAL, AND THE REPORTED CONDITION OF THE DEVICE OVERHEATING WAS DUPLICATED. BASED ON THE INVESTIGATION DETAILS, THE LIKELY CAUSE WAS CORROSION AND PROBLEMS WITH THE ROTOR, MOTOR, AND BEARINGS, WHICH WERE EACH REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DRILL BEGAN OVERHEATING WHILE THE EQUIPMENT WAS BEING TESTED. THERE WAS NO PT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERSAL DRILL ERL STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK