BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANTA SST GRAFTER

    MDR report key: 2963644 · Received January 2, 2013

    Report

    Report Number
    1219977-2012-00130
    Event Type
    Injury
    Date Received
    January 2, 2013
    Report Date
    September 17, 2010
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    DSY
    PMA / PMN Number
    K010516
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT WAS REMOVED FROM THE PACKAGING AND WAS VISUALLY INSPECTED. ONLY THE (B)(4) GDS COMPONENTS WERE RETURNED (THE GRAFT WAS NOT INCLUDED WITH THE RETURN AS IT WAS SAFELY IMPLANTED IN THE PT). ONE OF THE GDS WAS FOUND TO BE FULLY INTACT. THE OTHER GDS WAS FOUND WITHOUT THE METAL SLEEVE INSTALLED OVER THE PLASTIC ANCHOR AND THE GRAFT HAD PULLED OFF THE ANCHOR. IT WAS ALSO NOTED THAT THERE WERE HEAVY TOOLING MARKS ON THE PLASTIC ANCHOR ON THE GDS THAT FAILED. THE METAL SLEEVE AND SWIVEL HAD SOME LIGHT TOOLING MARKS ON THEM. AFTER THE VISUAL INSPECTION WAS COMPLETED THE DEVICE HISTORY FILE WAS REVIEWED FOR THIS LOT OF GRAFTS. ALL THE MECHANICAL, DIMENSIONAL AND VISUAL REQUIREMENTS MET SPECIFICATION FOR THIS PARTICULAR LOT OF GRAFTS. AN ENGINEERING STUDY WAS THEN CONDUCTED TO LOOK AT THE GDS TENSILE STRENGTH FOR 6MM ADVANTA SST PRODUCT. (B)(4). THE ASSEMBLY PROCESS TO INSTALL THE GDS COMPONENTS WAS REVIEWED. THERE IS NOWHERE IN THE MFG ASSEMBLY PROCESS WHERE THE PHYSICAL DAMAGE COULD HAVE OCCURRED. IT IS UNCLEAR WHERE THE DAMAGE ON THE RETURNED GDS CAME FROM. BASED ON THE EVAL CONDUCTED FOR THE RETURNED DEVICE, IT IS INCONCLUSIVE TO HOW OR WHY THE GDS SLEEVE DISLODGED. DUE TO THE HEAVY DAMAGE FOUND ON THE GDS COMPONENTS AND THE LACK OF INFO REGARDING HOW THIS DAMAGE OCCURRED, IT IS NOT POSSIBLE TO REACH A DEFINITIVE ROOT CAUSE FOR THE FAILURE DESCRIBED ON THIS RETURN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GRAFT ALLEGEDLY MALFUNCTIONED WHEN THE GRAFT WAS TUNNELED WHEN THE METAL COMPONENTS CAME APART AND A PORTION OF THE METAL WAS LEFT IN THE PT. X-RAY WAS USED TO FIND THE METAL PIECE. TOOLS WERE USED TO TRY AND RETRIEVE IT. THE DOCTOR FINALLY RETRIEVED IT USING BOTH INDEX FINGERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1407 ADVANTA SST GRAFTER DSY ATRIUM MEDICAL CORP. 25007 AI23913

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention