BEUDAMED
    FDA Adverse Event Other Summary report: N

    QUILL KNOTLESS TISSUE CLOSURE DEVICE

    MDR report key: 2640634 · Received June 20, 2012

    Report

    Report Number
    3008845715-2012-00003
    Event Type
    Other
    Date Received
    June 20, 2012
    Date of Event
    May 17, 2012
    Report Date
    June 18, 2012
    Manufacturer
    ANGIOTECH PUERTO RICO INC.
    Product Code
    NEW
    PMA / PMN Number
    K051609
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE INVOLVED IN THE INCIDENT REPORTED IS NOT AVAILABLE FOR EVAL, IT WAS DISCARDED. AT THIS MOMENT NO UNOPENED SAMPLES HAVE BEEN RETURNED TO ANGIOTECH PUERTO RICO, INC. FOR EVAL. METHOD: THE ACTUAL DEVICE INVOLVED IN THE INCIDENT REPORTED IS NOT AVAILABLE FOR EVAL, IT WAS DISCARDED. RESULTS/CONCLUSIONS: RELEVANT PORTIONS OF THE DEVICE HISTORY RECORD WERE REVIEWED FOR CORRESPONDING ISSUES IDENTIFIED DURING THE MFG PROCESS OR AT FINAL INSPECTION. FINISHED GOOD PRODUCT WAS RECEIVED INTO INVENTORY WITHOUT QUALITY ISSUES. (B)(4). ITEM #RA-1065Q, QUILL KNOTLESS TISSUE CLOSURE DEVICE 2T11 #2 PDO 36 X 36 SIZE/MATERIAL, LOT MP04600.

    Description of Event or Problem · 1

    TKA PROCEDURE USING #2 PDO TO CLOSE THE CAPSULE. PT EXPERIENCED A POST OP DEHISCENCE AND WAS TAKEN BACK TO THE OPERATING ROOM FOR AN I & D PROCEDURE. SURGEON NOTED AT THIS TIME THAT THE QUILL PRODUCT WAS NO LONGER INTACT. REF. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUILL KNOTLESS TISSUE CLOSURE DEVICE BARBED MATERIAL/NEEDLES NEW ANGIOTECH PUERTO RICO INC. RA-1065Q MP04600

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention NONE MADE AVAILABLE