BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORDLESS DRIVER 2 HANDPIECE

    MDR report key: 2955100 · Received February 11, 2013

    Report

    Report Number
    0001811755-2013-00247
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 29, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HRX
    PMA / PMN Number
    K943323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE DEVICE EVALUATION THE ALLEGED FAILURE OF BALL BEARINGS FALLING OUT OF THE DEVICE COULD NOT BE DUPLICATED. NO LOOSE BALL BEARINGS WERE FOUND WITHIN THE DEVICE, AND NO BALL BEARINGS WERE FALLING OUT OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE USER FACILITY, BALL BEARINGS WERE FALLING OUT OF THE CORDLESS DRIVER. UPON FOLLOW-UP, THE USER FACILITY WAS NOT ABLE TO PROVIDE ANY FURTHER INFORMATION REGARDING THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58643 CORDLESS DRIVER 2 HANDPIECE ARTHROSCOPE HRX STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1