BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMAX 2 PLUS MOTOR

    MDR report key: 4260142 · Received November 18, 2014

    Report

    Report Number
    1045834-2014-14958
    Event Type
    Malfunction
    Date Received
    November 18, 2014
    Date of Event
    September 5, 2014
    Report Date
    October 23, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    PK080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND OBSERVED THE LOCKING "EARS" ARE WORN. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. AN ASSESSMENT WAS PERFORMED ON THE DEVICE WHICH FOUND THAT THE DEVICE WAS HEATING UP FAST AND MADE AN UNUSUAL NOISE. IT WAS DETERMINED THAT THIS WAS DUE TO A BROKEN DRIVE SHAFT WHICH WAS INDICATIVE OF APPLYING EXTREME FORCE WHILE IN USE. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO MISUSE, ABUSE AND/OR USER 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 THAT DURING AN UNSPECIFIED PROCEDURE IN A CADAVER LABORATORY, IT WAS OBSERVED THAT THE LOCKING "EARS" OF THE MOTOR DEVICE WERE WORN. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DISCOVERED THAT THE MOTOR DEVICE WAS HEATING UP QUICKLY AND AN UNUSUAL NOISE. THERE WERE NO DELAYS AS A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS NO PATIENT INVOLVEMENT REPORTED AS THE DEVICE WAS USED IN A CADAVER LABORATORY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. 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
    746470 EMAX 2 PLUS MOTOR MOTOR, DRILL, ELECTRIC - HANDPIECE HBC DEPUY SYNTHES POWER TOOLS NA

    Patients

    Seq Age Sex Outcome Treatment
    1