BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERNAL SCREWDRIVER

    MDR report key: 611124 · Received May 25, 2005

    Report

    Report Number
    9615741-2005-00016
    Event Type
    Malfunction
    Date Received
    May 25, 2005
    Report Date
    May 24, 2005
    Manufacturer
    NEWDEAL S.A.
    Product Code
    KXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE PRODUCT WAS DELIVERED FOR A SURGERY ON 4/2005. IT WAS REPORTED THAT THE INTERNAL SCREWDRIVER WAS DELIVERED BROKEN. HOWEVER THE SURGEON DID NOT REALIZE IT UNTIL AFTER TRYING TO SET UP TWO IMPLANTS WITHOUT SUCCESS. ANOTHER SCREWDRIVER WAS DELIVERED IN URGENCY AND THE SURGEON USED IT TO COMPLETE THE SURGERY. THE SURGERY WAS DELAYED ABOUT TWO HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERNAL SCREWDRIVER KALIX ASSOCIATED IMPLANT INSTRUMENTS KXX NEWDEAL S.A. * D1T9

    Patients

    Seq Age Sex Outcome Treatment
    1 *