BEUDAMED
    FDA Adverse Event Other Summary report: N

    QUILL SRS

    MDR report key: 1849011 · Received September 22, 2010

    Report

    Report Number
    2522801-2010-00027
    Event Type
    Other
    Date Received
    September 22, 2010
    Date of Event
    August 26, 2010
    Report Date
    September 22, 2010
    Manufacturer
    SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)
    Product Code
    NEW
    PMA / PMN Number
    K051609
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL "USED" DEVICES WERE NOT RETURNED. HOWEVER, STERILE DEVICES FROM THE REPORTED FINISHED GOOD LOTS WERE RETURNED TO ANGIOTECH FOR EVALUATION. PHOTOS OF THE DEHISCED INCISION WERE ALSO PROVIDED FOR REVIEW. THIS EVENT WAS INITIALLY REPORTED TO CRITICAL ASSIST AND THEN FORWARDED TO ANGIOTECH. TWO (2) OTHER FINISHED GOOD LOTS WERE ALSO REPORTED. THE PRODUCT INFORMATION IS AS FOLLOWS: QUILL SRS #1 PDO; MODEL/CATALOG #: RA-1059Q; LOT #: M597160; EXPIRATION DATE: 02/28/2011; DEVICE MANUFACTURE DATE: 02/2009; 510(K): K051609. QUILL SRS 2-0 MONODERM; MODEL/CATALOG #: YA-1024Q; LOT #: M428900; EXPIRATION DATE: 05/31/2012; DEVICE MANUFACTURE DATE: 05/2010; 510(K): K072028. (B)(4), QUILL SRS ITEM #RA-1065Q, RA-1059Q, YA-1024Q, #2 PDO, #1 PDO, 2-0 MONODERM, LOT M394050, M597160, M428900. METHOD: THE ACTUAL DEVICES WERE NOT RETURNED FOR EVALUATION. HOWEVER, STERILE DEVICES FROM THE SAME REPORTED FINISHED GOOD LOTS WERE RETURNED TO ANGIOTECH AND FORWARDED TO THE QUALITY ASSURANCE LABORATORY. THE SAMPLES UNDERWENT THE STANDARD PRE AND POST HYDROLYSIS TESTING FOR THE SPECIFIC SUTURE MATERIAL. PHOTOGRAPHS OF THE DEHISCED INCISION WERE ALSO PROVIDED FOR REVIEW. RESULTS/CONCLUSIONS: ALL RETURNED DEVICES MET ANGIOTECH AND (B)(6) REQUIREMENTS. RELEVANT PORTIONS OF THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO CORRESPONDING ISSUES WERE IDENTIFIED. ACCOMPANYING PHOTOS REVEAL LARGE HEMATOMA OF THE PROXIMAL TIBIA, SUGGESTIVE OF A FALL OR OTHER SIMILAR TRAUMA. HOWEVER, MECHANISM HAS NOT BEEN CONFIRMED SINCE SUPERVISING NURSE COULD NOT BE CONTACTED.

    Description of Event or Problem · 1

    MR. (B)(6) REPORTED THAT FORTY-EIGHT (48) HOURS POST OPERATIVE, WHILE STILL UNDER THE HOSPITAL'S CARE, A PT EXPERIENCED WOUND DEHISCENCE OF THE DEEP FASCIA SUPERFICIAL AND CAPSULAR LAYERS FOLLOWING A TOTAL KNEE REPLACEMENT PROCEDURE. QUILL SRS PDO, SIZE #2 WAS USED TO CLOSE THE CAPSULE, SIZE #1 PDO FOR THE DEEP LAYER AND SIZE 2-0 MONODERM SUTURE WAS USED TO CLOSE THE SKIN. THE DEHISCENCE OCCURRED IN THE SHOWER, IN THE PRESENCE OF A RN, WHILE THE PT'S KNEE WAS IN FLEXION 90 DEGREES. THE KNEE WAS IMMEDIATELY WRAPPED AND THE INCISION WAS WASHED, STERILIZED AND REPAIRED IN THE OPERATING ROOM THE SAME DAY. ACCOMPANYING PHOTOS REVEALED A LARGE HEMATOMA OF THE PROXIMAL TIBIA WAS PRESENT, SUGGESTIVE OF A FALL. HOWEVER, MECHANISM HAS NOT BEEN CONFIRMED SINCE SUPERVISING NURSE COULD NOT BE CONTACTED. SWABS WERE ALSO TAKEN AND SENT TO THE LABORATORY. THE PT WAS ADMINISTERED XERALB FOR DVT POST-OPERATIVE AND ANTI HT MEDICATION. IT WAS NOTED THAT THIS SURGEON HAD FIVE (5) SUPERVISED CASES WHILE TRIALING QUILL SRS. THE SURGEON HAS TWO (2) DIFFERENT ASSISTANTS THAT WERE SUPERVISED USING QUILL SRS FOR INITIAL TRIAL THEN NORMALLY CLOSED ONLY THE SUBCUTICULAR LAYERS ON THEIR OWN. THE SURGEON WAS PRESENT AND ASSESSING AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUILL SRS BARBED SUTURE/NEEDLE NEW SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH) RA-1065Q M394050

    Patients

    Seq Age Sex Outcome Treatment
    1 Other