BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STANDARD INSERTION HANDLE

    MDR report key: 2781870 · Received October 11, 2012

    Report

    Report Number
    8030965-2012-01031
    Event Type
    Malfunction
    Date Received
    October 11, 2012
    Date of Event
    September 14, 2012
    Report Date
    September 14, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    DURING A LATERAL ENTRY FEMORAL NAIL INSERTION PROCEDURE, THE SURGEON MET RESISTANCE WHILE REMOVING THE INSERTION HANDLE. THE SURGEON REPORTEDLY PULLED VERY HARD AND HEARD A "POP" SOUND AND REALIZED IT WAS THE SMALL TOOTH ON THE INSERTION HANDLE THAT BROKE OFF. THE SMALL TOOTH OF THE HANDLE WAS RETRIEVED. X-RAYS WERE TAKEN AND THE RESULTS WERE NEGATIVE OF FOREIGN BODIES IN THE OPERATIVE SITE AND NO HARM TO THE PATIENT WAS NOTED. THE FEMORAL NAIL WAS REPORTEDLY INSERTED WITH A BACK-UP INSERTION HANDLE WHICH EXTENDED THE CASE BY 10 MINUTES. THE SURGEON WAS PLEASED WITH THE RESULTS OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STANDARD INSERTION HANDLE STANDARD INSERTION HANDLE KTT SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR