BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILK SUTURE 30"(75CM) 0 BLK

    MDR report key: 9268676 · Received November 1, 2019

    Report

    Report Number
    2210968-2019-89406
    Event Type
    Malfunction
    Date Received
    November 1, 2019
    Date of Event
    October 2, 2019
    Report Date
    October 7, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAP
    UDI-DI
    10705031044418
    PMA / PMN Number
    K946173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT TO THE FDA: 01/29/2020. ADDITIONAL INFORMATION: H6. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT AL8307, AND NO NON-CONFORMANCES WERE IDENTIFIED. ADDITIONAL H3 INVESTIGATION SUMMARY: IT WAS REPORTED BREAKAGE SUTURE. ONE NEEDLE-SUTURE PIECE OF PRODUCT CODE K834, LOT AL8307 WAS RECEIVED FOR ANALYSIS. DURING THE VISUAL INSPECTION OF THE OPENED SAMPLE, THE SWAGE AND ATTACHMENT AREA WERE NOTED TO BE AS EXPECTED. HOWEVER, MARKS ON THE BODY NEEDLE AND THE END OF THE SUTURE PIECES CUT THAT APPEARS TO BE BY THE USE OF A SURGICAL INSTRUMENT COULD BE OBSERVED. THE OTHER SECTION OF THE SUTURES WAS NOT RETURNED FOR ANALYSIS AND DUE TO THE CONDITION OF THE SAMPLES THE FUNCTIONAL TEST CAN¿T BE PERFORMED. AS WITH ANY DEVICE, CARE SHOULD BE TAKEN TO AVOID DAMAGE TO THE STRAND WHEN HANDLING. AVOID THE CRUSHING OR CRIMPING ACTION OF THE SURGICAL INSTRUMENTS, SUCH AS NEEDLE HOLDERS AND FORCEPS. THE MANUFACTURING RECORDS WERE REVIEWED, AND THE MANUFACTURING/PACKAGING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS BATCH. DUE TO CONDITION OF THE SAMPLES, THE ASSIGNABLE CAUSE OF PERFORMANCE BREAKAGE SUTURE SUGGESTS AN IMPROPER HANDLING ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: PLEASE PROVIDE THE SPECIFIC NUMBER OF SUTURES THAT BROKE DURING THIS PROCEDURE. CUSTOMER CONFIRMED THERE WERE 5 BROKEN THREADS. NOTE: EVENTS REPORTED IN 2210968-2019-89406, 2210968-2019-89410, 2210968-2019-89414, 2210968-2019-89415 AND 2210968-2020-00788.

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE, THE DEVICE HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED FOR EVALUATION, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE BROKE WHEN TRYING TO PERFORM THE KNOTTING. THE SURGEON USED MORE THREADS THAN USUAL. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1059480 SILK SUTURE 30"(75CM) 0 BLK SUTURE, NONABSORBABLE, SILK GAP ETHICON INC. K834H AL8307 10705031044418

    Patients

    Seq Age Sex Outcome Treatment
    1