BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOCRYL SUTURE 27"(70CM) 5-0 VIO

    MDR report key: 11221473 · Received January 25, 2021

    Report

    Report Number
    2210968-2021-00637
    Event Type
    Malfunction
    Date Received
    January 25, 2021
    Date of Event
    December 29, 2020
    Report Date
    December 30, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    UDI-DI
    10705031058675
    PMA / PMN Number
    K960653
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. EVALUATION: AN EMPTY OPENED FOIL, A DETACHED NEEDLE AND A DISPENSED SUTURE OF PRODUCT WERE RECEIVED FOR EVALUATION. DURING THE VISUAL INSPECTION OF THE SAMPLE, THE SWAGE AND ATTACHMENT AREA WERE NOTED TO BE AS EXPECTED. THE BARREL HOLE WAS EXAMINED UNDER MAGNIFICATION AND REMNANT SUTURE WAS NOTED, THE SUTURE END WAS SEVERELY CUT (DAMAGED), RESULTING IN A CLIP OFF DEFECT. NO FURTHER FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITION OF THE RETURNED DEVICE. THE CLIP OFF DEFECT HAS BEEN CORRELATED TO THE MANUFACTURING PROCESS. THIS IS CAUSED BY EXCESSIVE PRESSURE ON THE SUTURE DURING SWAGING OF THE NEEDLE AND CONSEQUENTLY BREAKING AS PART OF OUR QUALITY PROCESS, THE MANUFACTURING RECORDS OF THIS LOT-SERIAL NUMBER WERE REVIEWED, AND THE MANUFACTURING STANDARDS WERE MET PRIOR TO THE RELEASE OF THIS BATCH. COMPLAINT INFORMATION WILL BE INCLUDED IN COMPLAINT TRENDING THAT IS REVIEWED ON A REGULAR BASIS TO DETERMINE IF FURTHER ACTION IS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A DENTAL PROCEDURE ON (B)(6) 2020 AND THE SUTURE WAS USED. DURING SURGERY, THE NEEDLE POPPED OFF SUTURE WHILE SUTURING GUM TISSUE. A LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123975 MONOCRYL SUTURE 27"(70CM) 5-0 VIO SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC. Y303H QHMDAE 10705031058675

    Patients

    Seq Age Sex Outcome Treatment
    1