BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AL-III W/FOOT CONTROL

    MDR report key: 3182624 · Received June 21, 2013

    Report

    Report Number
    1045834-2013-02585
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    August 11, 2011
    Report Date
    August 12, 2011
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    GEY
    PMA / PMN Number
    K970530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY DEPUY SYNTHES POWER TOOLS. THE DEVICE WAS EVALUATED AND THE REPORTED CONDITION OF "DAMAGED HOSE" WAS CONFIRMED. RELIABILITY ENGINEERING DETERMINED THAT THERE WAS A CUT/HOLE IN THE HOSE. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA STATING THAT THE DEVICE HAD "HOSE DAMAGE." THE DEVICE WAS NOT BEING USED DURING SURGERY. IT IS UNKNOWN IF INJURIES OR MEDICAL INTERVENTION OCCURRED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282899 AL-III W/FOOT CONTROL MOTOR, SURGICAL INSTRUMENT, AC-POWERED - FOOT CONTROL GEY DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1