BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AL-III W/FOOT CONTROL

    MDR report key: 3984299 · Received December 18, 2013

    Report

    Report Number
    1045834-2013-16086
    Event Type
    Malfunction
    Date Received
    December 18, 2013
    Date of Event
    July 16, 2012
    Report Date
    July 16, 2012
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    GEY
    PMA / PMN Number
    K970530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    REPORT RECEIVED FROM (B)(6) STATING THAT THE DEVICE NEEDED TO BE SERVICED. DURING SERVICING, IT WAS FOUND THAT THE DEVICE HAD AN "AIR LEAK." IT IS UNK IF THE DEVICE WAS BEING USED DURING SURGERY. IT IS UNK IF THERE WERE ANY PATIENT OR USER INJURIES THAT OCCURRED. THERE WAS NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663745 AL-III W/FOOT CONTROL GEY DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1