BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XMAX MOTOR

    MDR report key: 3983892 · Received December 18, 2013

    Report

    Report Number
    1045834-2013-16184
    Event Type
    Malfunction
    Date Received
    December 18, 2013
    Date of Event
    August 2, 2012
    Report Date
    August 2, 2012
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    ERL
    PMA / PMN Number
    K965080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY DEPUY SYNTHES POWER TOOLS. THE INVESTIGATION IS STILL IN PROCESS. WHEN THE INVESTIGATION HAS BEEN COMPLETED OR ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT. REF: (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA STATING THAT THE DEVICE WAS HAVING AN AIR LEAK AND WAS NOT WORKING PROPERLY. IT IS KNOWN THAT THE DEVICE WAS USED DURING SURGERY. NO INJURIES OR MEDICAL INTERVENTION WERE REPORTED TO HAVE OCCURRED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663269 XMAX MOTOR ERL DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1