BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XMAX MOTOR

    MDR report key: 3811235 · Received October 11, 2013

    Report

    Report Number
    1045834-2013-05872
    Event Type
    Malfunction
    Date Received
    October 11, 2013
    Date of Event
    July 25, 2012
    Report Date
    July 26, 2012
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    ERL
    PMA / PMN Number
    K965080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN REC'D BY DEPUY SYNTHES POWER TOOLS. THE INVESTIGATION IS STILL IN PROCESS. WHEN THE INVESTIGATION HAS BEEN COMPLETED OR ADD'L INFO BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT REC'D FROM UNITED STATES INDICATING THAT DEVICE "CORD DAMAGED." IT IS KNOWN THE DEVICE WAS USED IN SURGERY AND THERE WAS NO INJURY OR MEDICAL INTERVENTION. THERE WAS NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523970 XMAX MOTOR DRILL, SURGICAL, ENT (PNEUMATIC) - HANDPIECE, PRODUCT CODE: ERL ERL DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1