BEUDAMED
    FDA Adverse Event Other Summary report: N

    QUILL KNOTLESS TISSUE CLOSURE DEVICE

    MDR report key: 2312372 · Received October 26, 2011

    Report

    Report Number
    2522801-2011-00029
    Event Type
    Other
    Date Received
    October 26, 2011
    Date of Event
    June 1, 2011
    Report Date
    October 26, 2011
    Manufacturer
    SURGICAL SPECIALTIES CORPORATION (DBA ANGIOTECH)
    Product Code
    NEW
    PMA / PMN Number
    K051609
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ITEM/LOT CODE INFO WAS NOT PROVIDED. THEREFORE, THE EXPIRATION DATE AND MANUFACTURING DATE ARE UNK. NO SAMPLES WERE AVAILABLE FOR EVALUATION. THEREFORE, NO TESTING CAN BE PERFORMED. ADDITIONAL ITEM REPORTED BY THIS CUSTOMER: 3-0 MONODERM. MODEL/CATALOG #: UNKNOWN. LOT #: UNKNOWN. EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. THE 510(K) #: K072028. METHOD: THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. NO PRODUCT EVALUATION CAN BE PERFORMED. RESULTS/CONCLUSION: THE DEVICE WAS NOT RETURNED FOR EVALUATION. NO PRODUCT EVALUATION CAN BE PERFORMED. WITHOUT THE FINISHED GOOD LOT NUMBER, RELEVANT PORTIONS OF THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. THE ROOT CAUSE FOR THE POST OPERATIVE DEHISCENCE WAS ADJUDICATED AS "USER ERROR". A MEDICAL AFFAIRS REPRESENTATIVE DISCUSSED THE EVENT WITH THIS SURGEON AND PROVIDED PRODUCT AND PLACEMENT INFO. ANGIOTECH REFERENCE: (B)(4). ITEM # UNKNOWN, QUILL KNOTLESS TISSUE CLOSURE DEVICE, #2 PDO, 3-0 MONODERM LOT UNKNOWN.

    Description of Event or Problem · 1

    THE DATE OF EVENT IS ESTIMATED: A SURGEON WHO IS A NEW QUILL USER PERFORMED A TOTAL KNEE ARTHROPLASTY PROCEDURE USING A #2 PDO QUILL FOR CAPSULAR CLOSURE (IN EXTENSION) AND USED A 3-0 MONODERM DEVICE FOR THE SUBCUTICULAR LAYER (IN APPROXIMATELY 70 DEGREES OF FLEXION). THE SURGEON DID NOT PLACE ANY TYPE OF PRODUCT IN THE SUBCUTANEOUS TISSUE. THE KNEE WAS CYCLED THROUGH ROM FOLLOWING THE PROCEDURE AND IT HELD WELL. APPROXIMATELY TWO (2) WEEKS POSTOPERATIVELY, THE WOUND DEHISCED WITH NO HISTORY OF A FALL OR ANY OTHER TRAUMA. THE PT WAS RETURNED TO SURGERY AND AN EXPLORATION SHOWED THE DEHISCENCE INVOLVED THE SUPERFICIAL LAYERS WITH THE CAPSULAR LAYER STILL INTACT. THE PT'S INCISION WAS WASHED OUT AND RE-CLOSED USING CONVENTIONAL SUTURE. NO FURTHER ISSUES WERE REPORTED. THE SURGEON REALIZED THIS WAS HIS ERROR DUE TO CHOOSING ONE SHORT ACTING ABSORBABLE DEVICE TO MANAGE BOTH SUBCUTANEOUS AND SUBCUTICULAR LAYERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUILL KNOTLESS TISSUE CLOSURE DEVICE BARBED SUTURE/NEEDLES NEW SURGICAL SPECIALTIES CORPORATION (DBA ANGIOTECH) UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention