BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DII CONTROLLER

    MDR report key: 7027148 · Received November 14, 2017

    Report

    Report Number
    1643264-2017-01722
    Event Type
    Malfunction
    Date Received
    November 14, 2017
    Date of Event
    November 6, 2017
    Report Date
    January 10, 2018
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HRX
    PMA / PMN Number
    K062849
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED FOR EVALUATION. THERE WAS A RELATIONSHIP FOUND BETWEEN THE RETURNED DEVICE AND THE REPORTED INCIDENT. A VISUAL INSPECTION WAS PERFORMED ON THE PRODUCT AND FOUND DAMAGE TO PORT A AND PORT B MOTOR DRIVE UNIT (MDU) RECEPTACLES. PORT A RECEPTACLE APPEARS DAMAGED. THE SURFACE IS GOUGED, POTENTIALLY FROM TURNING AN MDU CONNECTOR WHILE ATTEMPTING TO INSERT IT INTO THE CONTROL UNIT. PORT A DOES NOT RECOGNIZE THE TEST MDU WHEN INSERTED, WHICH INDICATES INTERNAL DAMAGE TO THE HARNESS. PORT B RECEPTACLE IS DAMAGED AND APPEARS TO BE PARTIALLY MELTED, POSSIBLY FROM PLUGGING IN A SHORTED OUT MDU. THE TEST MDU CANNOT BE INSERTED INTO IT. PRODUCT PASSED FUNCTIONAL TESTING USING A KNOWN GOOD MDU TEST RECEPTACLE FOR EACH PORT. THE COMPLAINT WAS CONFIRMED AND THE ROOT CAUSE HAS BEEN DETERMINED TO BE AN ELECTRICAL COMPONENT FAILURE. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION OR WOULD NOT BE ABLE TO PERFORM AS INTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE SHOWS AN ERROR MESSAGE, PORT A CIRCUIT SHORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808514 DII CONTROLLER ARTHROSCOPE HRX SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1