BEUDAMED
    FDA Adverse Event Other Summary report: N

    QUILL SRS

    MDR report key: 1961732 · Received January 12, 2011

    Report

    Report Number
    2522801-2011-00002
    Event Type
    Other
    Date Received
    January 12, 2011
    Date of Event
    December 17, 2010
    Report Date
    January 12, 2011
    Manufacturer
    SURGICAL SPECIALTIES CORPORATION (DBA ANGIOTECH)
    Product Code
    NEW
    PMA / PMN Number
    K051609
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL FAILED DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, STERILE PRODUCT FROM THE SAME FINISHED GOODS LOT WERE RETURNED FOR TESTING ON (B)(6) 2011 AND FORWARDED TO ANGIOTECH'S QUALITY ASSURANCE LABORATORY. ADDITIONAL ITEM REPORTED BY THIS CUSTOMER: #2PDO: MODEL/CATALOG#: RA-1065Q, LOT#: M434070, EXPIRATION DATE: 05/31/2011, DEVICE MANUFACTURE DATE: 05/2010, 510(K) #: K0516709. METHOD: THE ACTUAL FAILED DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, STERILE PRODUCT FROM THE SAME FINISHED GOODS LOT WERE RETURNED REVIEW AND TESTING ON (B)(6) 2011 AND FORWARDED TO ANGIOTECH'S QUALITY ASSURANCE LABORATORY. RESULTS/CONCLUSIONS: THE RETURNED STERILE SAMPLES WERE VISUALLY EXAMINED PRIOR TO UNDERGOING PRE AND POST HYDROLYSIS TESTING PERFORMED BY A QUALITY ASSURANCE TECHNICIAN. ALL SAMPLES MET ANGIOTECH AND USP REQUIREMENTS. FURTHERMORE, RELEVANT PORTIONS OF THE DHR'S AND STERILITY RECORDS WERE REVIEWED AND THERE WERE NO CORRESPONDING ISSUES IDENTIFIED DURING MANUFACTURING OR FINAL RELEASE. TO DATE, NO OTHER COMPLAINTS HAVE BEEN REC'D FOR THE REPORTED FINISHED GOODS LOTS. ANGIOTECH REFERENCE: (B)(4). ITEM # RA-1065Q, QUILL SRS, #2 PDO, LOTS M512450, M434070.

    Description of Event or Problem · 1

    THE SURGEONS REPORTED THAT FOUR (4) DAYS POST OPERATIVE A RIGHT TOTAL KNEE ARTHROPLASTY PROCEDURE WHERE, QUILL SRS #2 PDO WAS USED FOR CAPSULE CLOSURE, QUILL SRS 0 PDO FOR THE INTERMEDIATE LAYER CLOSURE AND STAPLES FOR THE SKIN, THE PT EXPERIENCED A LARGE AMOUNT OF DRAINAGE FROM THE INCISION LINE. THE PT WAS TAKEN BACK TO THE OPERATING ROOM. THE SKIN AND SUBCUTANEOUS LAYERS WERE INTACT. HOWEVER, IT WAS NOTED THAT THE CAPSULE HAD DEHISCED APPROX 1.5 INCHES IN THE MIDDLE OF THE CLOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUILL SRS BARBED SUTURE/NEEDLE NEW SURGICAL SPECIALTIES CORPORATION (DBA ANGIOTECH) RA-1065Q M512450

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention