BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL NOSE GUIDE WIRE 100CM

    MDR report key: 1080917 · Received July 22, 2008

    Report

    Report Number
    1818910-2008-02934
    Event Type
    Injury
    Date Received
    July 22, 2008
    Date of Event
    January 5, 2008
    Report Date
    June 24, 2008
    Manufacturer
    DEPUY ACE S.A. 'R.L.
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS CONFIRMED THAT THE PT'S CANAL WAS LESS THAN 9MM BY TEMPLATING ON PRE-OP. THE SURGERY WAS GOING TO BE DONE BY REAMING UP TO 10MM AND INSERTION OF 9MM NAIL. A GUIDEWIRE WAS INSERTED AND REAMING STARTED FROM 8MM ON INTRAOPERATIVE, HOWEVER THE SURGEON COULD NOT INSERT THE REAMER FROM BOWED PORTION OF THE GUIDEWIRE WHERE IS AHEAD OF THE ENTRY POINT, SO HE PULLED OUT OF GUIDEWIRE BECAUSE THE CLIPPED GUIDEWIRE WAS CONFIRMED BY IMAGE. HE MAKES A DECISION AS THIS REAMER DOES NOT WORK DUE TO BOWED GUIDEWIRE AND TRIED INSERTING NEW GUIDEWIRE AFTER REAMING BY 13MM ENTRY REAMER. ONCE AGAIN, THE REAMER WAS STUCK AT SAME POSITION AS PREVIOUS TIME, THUS THE SURGEON HAS INSERTED AN IM NAIL. HOWEVER, HE DISCONTINUED TO INSERT THE NAIL AROUND LESSER TROCHANTER BECAUSE BOWED TIP OF THE NAIL WAS CONFIRMED BY IMAGE. FORTUNATELY, AN INCISION OF THE FRACTURED BONY PART WAS DONE DURING THE REDUCTION; THEREFORE, THE PT WAS TREATED USING A PLATE THE HOSPITAL HAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BALL NOSE GUIDE WIRE 100CM 87LXH LXH DEPUY ACE S.A. 'R.L. NA ZC6AL7

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR