BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPS MICRO DRIVER

    MDR report key: 4242486 · Received November 11, 2014

    Report

    Report Number
    0001811755-2014-04032
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 15, 2014
    Report Date
    October 15, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K943540
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON EVALUATION A DAMAGED PCB WAS DISCOVERED, WHICH CAN CAUSE OR CONTRIBUTE TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS IS IN PROGRESS; ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A PROCEDURE, THE TPS MICRO DRIVER WAS RUNNING IN SAFE MODE. THE DEVICE ALSO WOULD NOT GO IN THE CORRECT INTENDED DIRECTION. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. THE CASE WAS COMPLETED WITH THE SAME DEVICE WITHOUT ANY DELAY.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A PROCEDURE, THE TPS MICRO DRIVER WAS RUNNING IN SAFE MODE. THE DEVICE ALSO WOULD NOT GO IN THE CORRECT INTENDED DIRECTION. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. THE CASE WAS COMPLETED WITH THE SAME DEVICE WITHOUT ANY DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727886 TPS MICRO DRIVER BONE CUTTING INSTRUMENT AND ACCESSORIES DZJ STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1