BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILK SUTURE 30"(75CM) 0 BLK

    MDR report key: 9285673 · Received November 6, 2019

    Report

    Report Number
    2210968-2019-89603
    Event Type
    Malfunction
    Date Received
    November 6, 2019
    Report Date
    October 14, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAP
    UDI-DI
    10705031044418
    PMA / PMN Number
    K946173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT MAH862, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 01/15/2020. H3 DEVICE EVALUATION SUMMARY: IT WAS RECEIVED FOR ANALYSIS AN OPENED BOX WITH TWENTY-EIGHT UNOPENED SAMPLES OF PRODUCT CODE K834, LOT MAH862. THE COMPLAINT SAMPLE WAS NOT RETURNED FOR ANALYSIS. DURING THE VISUAL INSPECTION OF THIRTEEN UNOPENED SAMPLES, NO DEFECTS WERE FOUND ON THE PACKAGES. THE SAMPLES WERE OPENED, AND THE SWAGE AND ATTACHMENT AREA WERE NOTED TO BE AS EXPECTED. THE SUTURES WERE DISPENSED WITHOUT PROBLEMS AND EXAMINED ALONG OF THE STRAND AND NO DEFECTS, DAMAGED OR SUTURE BREAKAGE WERE NOTED. A FUNCTIONAL TEST WAS PERFORMED AND THE TENSILE STRENGTH FORCE WAS ABOVE THE MINIMUM REQUIREMENT. THE MANUFACTURING RECORDS WERE REVIEWED, AND THE MANUFACTURING/ PACKAGING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS BATCH. PER THE CONDITION OF THE REPRESENTATIVE SAMPLES, NO PERFORMANCE - BREAKAGE SUTURE WAS FOUND AND THE TESTED SAMPLES MET THE FINISHED GOODS REQUIREMENTS. REPRESENTATIVE SAMPLES RETURNED TO SUPPORT INVESTIGATION OF DEVICE ISSUES CAPTURED IN REPORTS 2210968-2019-89602, 2210968-2019-89603, AND 2210968-2019-89604. ANALYSIS RESULTS HAVE BEEN INCLUDED IN FOLLOW UP REPORTS FOR EACH.

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. PLEASE PROVIDE SPECIFIC NUMBER OF DEVICES WITH SUTURE BREAKAGE ISSUE DURING USE IN THE PROCEDURE. HOW WAS THE CASE COMPLETED? HAS THE PRODUCT BEEN RETURNED YET? NOTE: EVENTS REPORTED IN 2210968-2019-89602, AND 2210968-2019-89604.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PLASTIC SURGERY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE KEPT SNAPPING WHEN TYING OFF OR SUTURING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1083158 SILK SUTURE 30"(75CM) 0 BLK SUTURE, NONABSORBABLE, SILK GAP ETHICON INC. MAH862 10705031044418

    Patients

    Seq Age Sex Outcome Treatment
    1