BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMAX 2 PLUS MOTOR

    MDR report key: 3932067 · Received July 14, 2014

    Report

    Report Number
    1045834-2014-12441
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Report Date
    June 27, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    PK080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE. VISUAL AND FUNCTIONAL ASSESSMENTS WERE PERFORMED ON THE DEVICE AND IT WAS OBSERVED THAT THE CONNECTOR WAS LOOSE AND A PIN WAS PUSHED IN. THE PIN PUSHED BACK IN THE CONNECTOR WAS A RESULT OF THE CONNECTOR NOT BEING PROPERLY ALIGNED AND FORCED INTO THE FEMALE CONNECTOR WHEN PLUGGING IT INTO CONSOLE. THIS WAS WHAT CAUSED THE E5 AND E6 ERRORS. THEREFORE, THE REPORTED CONDITIONS WERE CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO COMPONENT DAMAGE DUE TO MISUSE/ABUSE AND POSSIBLE USER ERROR. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    DURING SUBSEQUENT FOLLOW-UP WITH THE CUSTOMER, ADDITIONAL INFORMATION WAS OBTAINED. IT WAS REPORTED THAT THE EVENT OCCURRED DURING SURGERY WHEN THE DEVICE WAS ATTEMPTED TO BE USED. IF ADDITIONAL INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A SUPPLEMENTAL MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MOTOR DEVICE DISPLAYED E5 AND E6 ERROR MESSAGES. IT WAS NOT REPORTED THAT THE MALFUNCTION OCCURRED DURING SURGERY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF THE EVENT WAS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409729 EMAX 2 PLUS MOTOR MOTOR, DRILL, ELECTRIC - HANDPIECE HBC DEPUY SYNTHES POWER TOOLS NA

    Patients

    Seq Age Sex Outcome Treatment
    1