BEUDAMED
    FDA Adverse Event Other Summary report: N

    QUILL SRS

    MDR report key: 981807 · Received January 15, 2008

    Report

    Report Number
    2522801-2008-00002
    Event Type
    Other
    Date Received
    January 15, 2008
    Date of Event
    January 27, 2008
    Report Date
    January 15, 2008
    Manufacturer
    SURGICAL SPECIALTIES CORP.
    Product Code
    GAB
    PMA / PMN Number
    K051609
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUTURE IS PDO AND WE DO NOT RE-STERILIZE SYNTHETIC ABSORBABLE SUTURES. IN ADDITION WE DO NOT TEST "USED" SUTURES THAT HAVE BEEN RETURNED FROM THE FIELD. IF THIS PRODUCT WERE TO BE TESTED, YOU WILL NOT BE GETTING AN ACCURATE READING ON THE PRODUCT AT THIS STAGE BECAUSE THE PDO IS A SYNTHETIC ABSORBABLE THAT WILL CONTINUE TO BREAK DOWN WHEN IT IS OUTSIDE OF THE SEALED PACKAGE, AND INTRODUCED TO MOISTURE. AS PER THE "IFU" (UNDER THE ACTION SECTION) THE RESULTS OF IMPLANTATION STUDIES OF QUILL SYNTHETIC ABSORBABLE BARBED THREADS IN ANIMALS INDICATE THAT APPROX 80% OF ITS ORIGINAL STRENGTH REMAINS AFTER TWO WEEKS OF IMPLANTATION. AT FOUR WEEKS POST IMPLANTATION, APPROX 80% OF ITS ORIGINAL TENSILE STRENGTH IS RETAINED AND AT SIX WEEKS, APPROX 40% OF ITS ORIGINAL TENSILE STRENGTH IS RETAINED. DATA OBTAINED FROM IMPLANTATION STUDIES IN RATS SHOW THAT HYDROLYTIC ABSORPTION OF THESE THREADS IS MINIMAL UNTIL ABOUT 120 DAYS, AND ESSENTIALLY COMPLETE WITHIN SIX MONTH. (UNDER THE PRECAUTIONS SECTION) AS WITH ANY SUTURE, CARE SHOULD BE TAKEN TO AVOID DAMAGE WHEN HANDLING. AVOID THE CRUSHING OR CRIMPING APPLICATION OF SURGICAL INSTRUMENTS, SUCH AS NEEDLE HOLDERS, AND FORCEPS, TO THE STRAND EXCEPT WHEN GRASPING THE FREE END DURING PLACING OF THE THREAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS NO INTEROPERATIVE PROBLEMS. A FEW HOURS POSTOPERATIVELY, THE PT HAD FELT A POP, AS REPORTED BY THE SALES REP, BUT SEEMED FINE UNTIL THE NEXT DAY, WHEN THERE WAS OOZING FROM THE LEFT POSTERIOR WOUND SITE. THE PHYSICIAN REEVALUATED THE PT. ALTHOUGH THE SURGEON NOTED NO VISIBLE DEHISCENCE, BASED ON HER EXAM, SHE REOPENED THE PT. THE FIRST TWO LAYERS WERE INTACT WHEN ASSESSED, THE SFS WAS OPEN, WHERE THE PHYSICIAN USED THE 2T9-0-PDO 24 X 24 QUILL. THE PHYSICIAN REMOVED THE PRODUCT AND THE PT UNDERWENT REVISION/REPAIR USING A DIFFERENT PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUILL SRS BARBED SUTURE AND NEEDLE GAB SURGICAL SPECIALTIES CORP. RA-1029Q M215040

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention