BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMB MICRO DRILL

    MDR report key: 2140379 · Received June 17, 2011

    Report

    Report Number
    1811755-2011-02189
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 26, 2011
    Report Date
    May 26, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE WAS RECEIVED AT THE MANUFACTURER FOR EVALUATION, AND THE REPORTED CONDITION OF THE DEVICE OVERHEATING WAS DUPLICATED. BASED ON THE INVESTIGATION DETAILS, A POSSIBLE CAUSE WAS PROBLEMS WITH THE ROTOR AND BEARINGS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDPIECE BEGAN OVERHEATING WHILE THE EQUIPMENT WAS BEING TESTED PRIOR TO THE START OF A SHOULDER ROTATOR CUFF REPAIR. THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO USER INJURY OR ANY OTHER ADVERSE CONSEQUENCES REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REMB MICRO DRILL HBE STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK