BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XMAX MOTOR

    MDR report key: 3984158 · Received December 18, 2013

    Report

    Report Number
    1045834-2013-16333
    Event Type
    Malfunction
    Date Received
    December 18, 2013
    Date of Event
    October 25, 2011
    Report Date
    October 26, 2011
    Manufacturer
    DEPUY SYNTHES POWER TOOLKS
    Product Code
    ERL
    PMA / PMN Number
    K965080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA STATING THAT THE DEVICE HAD HOLES IN THE AIR HOSE. THE DEVICE WAS BEING USED DURING SURGERY. THERE WERE NO USER OR PATIENT INJURIES. IT IS UNKNOWN IF MEDICAL INTERVENTION OR SURGICAL DELAY OCCURRED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664357 XMAX MOTOR ERL DEPUY SYNTHES POWER TOOLKS

    Patients

    Seq Age Sex Outcome Treatment
    1