BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMAX 2 PLUS MOTOR

    MDR report key: 3914858 · Received July 4, 2014

    Report

    Report Number
    1045834-2014-12293
    Event Type
    Malfunction
    Date Received
    July 4, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 9, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    PK080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND THE REPORTED CONDITION WAS DUPLICATED AND CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO MISUSE, ABUSE AND OR ERROR. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM (B)(6) THAT DURING AN ANTERIOR CERVICAL DISCECTOMY WITH FUSION (ACDF) SURGERY, IT WAS OBSERVED THAT THE MOTOR DEVICE MAXIMIZED AT 46,000 ROTATIONS PER MINUTE (RPMS). ACCORDING TO THE REPORT, THE ALLEGED MALFUNCTION OCCURRED WHEN THE SURGEON WAS PREPARING END PLATES DURING THE PROCEDURE. IT WAS REPORTED THAT A SPARE ATTACHMENT DEVICE WAS AVAILABLE. HOWEVER, THE SPARE ATTACHMENT DEVICE WAS TRIED AND HAD THE SAME RESULT. AS A RESULT, THERE WAS A THREE MINUTE DELAY TO THE SURGICAL PROCEDURE. A SPARE SET WAS OPENED TO OBTAIN A SPARE MOTOR DEVICE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH THE SPARE MOTOR DEVICE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. IT WAS REPORTED THERE WAS NO MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED. ALL AVAILABLE EVENT INFORMATION HAS BEEN DISCLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392815 EMAX 2 PLUS MOTOR MOTOR, DRILL, ELECTRIC - HANDPIECE HBC DEPUY SYNTHES POWER TOOLS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 ATTACHMENT DEVICE