BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMAX 2 PLUS MOTOR

    MDR report key: 3253852 · Received July 30, 2013

    Report

    Report Number
    1045834-2013-03728
    Event Type
    Malfunction
    Date Received
    July 30, 2013
    Date of Event
    August 29, 2011
    Report Date
    August 29, 2011
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY DEPUY SYNTHES POWER TOOLS. THE DEVICE WAS EVALUATED AND THE PROBLEM WAS CONFIRMED. THE HOSE / CORD WAS PULLED LOOSE OUT OF THE CONNECTOR END OF THE MOTOR ASSEMBLY. THE CONDITION OF THE HOSE / CORD WAS MOST LIKELY DUE TO HANDLING ISSUES AT THE CUSTOMER SITE. IT APPEARS THAT THE HOSE / CORD WAS PULLED ON INSTEAD OF THE CONNECTOR IN ORDER TO DISCONNECT THE MOTOR. THE INTERNAL MOTOR PARTS MOST LIKELY WERE EXPOSED TO MOISTURE DURING CLEANING DUE TO THE SEPARATION AND EXPOSURE. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM USA STATING THAT THE "HOSE COVERING WIRING DETACHED FROM END" OF THE DEVICE. THE DEVICE WAS NOT BEING USED DURING SURGERY. IT IS UNKNOWN IF INJURY OR MEDICAL INTERVENTION OCCURRED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356277 EMAX 2 PLUS MOTOR MOTOR, DRILL, ELECTRIC - HANDPEICE HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention