BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMAX 2 PLUS MOTOR

    MDR report key: 3113149 · Received May 9, 2013

    Report

    Report Number
    1045834-2013-02112
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 9, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MOTOR DEVICE WAS REC'D FOR EVAL. UPON COMPLETION OF THE EVAL, A SUPPLEMENTAL REPORT WILL BE SENT.

    Description of Event or Problem · 1

    REPORT REC'D FROM THE USA STATING THAT DURING A TOTAL KNEE EXPLANTATION PROCEDURE, AS THE SURGEON WAS CUTTING INTO THE TIBIAL STEM, IT WAS OBSERVED THAT THE SYSTEM CONSOLE "GENERATED AN E6 ERROR CODE." ACCORDING TO THE REPORT, THE SYSTEM WAS TURNED OFF, AS IT WAS OBSERVED THAT THE MOTOR DEVICE WAS OVERHEATING. THE SURGEON WRAPPED THE MOTOR DEVICE IN A COOL CLOTH. AFTER A FEW SECONDS DELAY, THE SYSTEM WAS RESTARTED AND SURGERY RESUMED. THE RPTR CLARIFIED THAT THE DEVICE HAD TO BE SHUT DOWN A TOTAL OF THREE TIMES DURING THE PROCEDURE, AND THE SURGERY WAS DELAYED A FEW SECONDS EACH TIME. AN ALTERNATE MOTOR DEVICE WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY. NO INJURIES OR MEDICAL INTERVENTION WERE REPORTED. THERE WAS NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204847 EMAX 2 PLUS MOTOR HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1