BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMAX 2 PLUS MOTOR

    MDR report key: 3181498 · Received June 21, 2013

    Report

    Report Number
    1045834-2013-02499
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 28, 2013
    Report Date
    May 29, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL HAND PIECE DEVICE HAS BEEN RETURNED. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND THE REPORTED CONDITION WAS CONFIRMED. TESTING WAS PERFORMED AND THE EVENT WAS DUPLICATED. FINDINGS REVEALED THAT THIS EVENT WAS DUE TO USAGE WEAR OVER TIME. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT ACCORDINGLY.(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HAND PIECE DEVICE WAS OVERHEATING DURING ROUTINE TESTING. THE REPORTER CONFIRMED THAT THE DEVICE WAS NOT BEING USED DURING SURGERY WHEN THE EVENT OCCURRED; NO INJURIES OR MEDICAL INTERVENTION WERE REPORTED. SEVERAL ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. 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
    282155 EMAX 2 PLUS MOTOR MOTOR, DRILL, ELECTRIC-HANDPIECE HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1