BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AL-III W/ FOOT CONTROL

    MDR report key: 3955288 · Received December 13, 2013

    Report

    Report Number
    1045834-2013-14123
    Event Type
    Malfunction
    Date Received
    December 13, 2013
    Date of Event
    February 1, 2011
    Report Date
    February 1, 2011
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    GEY
    PMA / PMN Number
    K970530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    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 ADD'L INFO BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT.

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA STATING THAT THE DEVICE WILL NOT LOCK INTO MOTOR. THE DEVICE WAS USED DURING SURGERY. NO INJURIES WERE REPORTED. IT IS UNK IF MEDICAL INTERVENTION OCCURRED. THERE WAS NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654128 AL-III W/ FOOT CONTROL GEY DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1