BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSET GMV 40G US EO

    MDR report key: 2163329 · Received July 8, 2011

    Report

    Report Number
    1818910-2011-11812
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 8, 2011
    Manufacturer
    DEPUY CMW
    Product Code
    LOD
    PMA / PMN Number
    K081163
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION REVEALED THAT THE POUCH HAD A SMALL SPLIT IN THE POUCH AT THE AREA AROUND THE MANUFACTURERS AND PRODUCTION SEAL JOINT. POWDER INGRESSES FOR APPROX 40MM ALONG THE PRODUCTION SEAL, AND 15MM ALONG THE MANUFACTURERS SEAL FROM THE SPLIT. THE GRID LACQUER IS EVIDENT ON THE POUCH, BUT POWDER IS CLEARLY EVIDENT IN THE MANUFACTURERS SEAL IN SEVERAL PLACES WITHOUT TRAVELLING THE FULL DISTANCE OF THE SEAL, I.E. NOT FULLY BROKEN THROUGH. POTENTIALLY DURING THE FILLING OPERATION, POWDER RESIDUE HAS REMAINED IN THE CORNER OF THE PRODUCTION SEALING AREA OF THE POWDER BAG, THIS MAY HAVE LED TO A WEAKER SEAL AND DURING THE FURTHER PACKAGING OPERATIONS THE SEALS MAY HAVE BEEN STRESSED AS THEY ARE FOLDED INTO THE INNER POUCH AND THE FOIL POUCH. DURING TRANSPORTATION AND UNDER PRESSURE OF AIR FREIGHT, THE POWDER HAS MOVED IN THE POWDER BAG AND ALONG THE SEALS CAUSING THE SMALL SPLIT IN THE SEAL. RETRAINING OF THE POWDER FILL TEAM WILL TAKE PLACE TO ENSURE THAT THEY ARE AWARE OF THIS TYPE OF ISSUE. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    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

    DEPUY SMART SET GMV CEMENT STERILE POWDER PACK WAS UNSEALED UPON OPENING. A SMALL PORTION, ABOUT 1/2" LONG OF THE PACKAGE WAS UNSEALED/UNGLUED. BREACHED THE STERILE FIELD IN THE OPERATING ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMARTSET GMV 40G US EO 87 LOD, MBB LOD DEPUY CMW NA 3249525

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention