BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORDLESS DRIVER 3

    MDR report key: 3083677 · Received April 29, 2013

    Report

    Report Number
    0001811755-2013-00943
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 8, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HRX
    PMA / PMN Number
    K943323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OF THE DEVICE HEATING UP WAS CONFIRMED. THE DEVICE HAD A DAMAGED MOTOR BEARING, WHICH CAN RESULT IN HEAT DUE TO INCREASED FRICTION BETWEEN THE BEARING AND THE MOTOR SHAFT. THE DEVICE WAS REPAIRED, ROUTINE MAINTENANCE WAS PERFORMED, AND IT WAS RETURNED TO THE USER FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CORDLESS DRIVER WAS OVERHEATING AND RUNNING LOUD DURING PERFORMANCE TESTING. NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CORDLESS DRIVER WAS OVERHEATING AND RUNNING LOUD DURING PERFORMANCE TESTING. NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185319 CORDLESS DRIVER 3 ARTHROSCOPE HRX STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1