BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILK BLK 18IN 6-0 D/A G-6 PRM

    MDR report key: 18080813 · Received November 6, 2023

    Report

    Report Number
    2210968-2023-08601
    Event Type
    Malfunction
    Date Received
    November 6, 2023
    Date of Event
    October 11, 2023
    Report Date
    November 6, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAP
    UDI-DI
    10705031010451
    PMA / PMN Number
    K946173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #: (B)(4). H6 COMPONENT CODE: G07002 - DEVICE NOT RETURNED. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. 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. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED VIA: DID THE NEEDLE FALL INTO THE PATIENT? NO, THE SUTURE WAS OPENED AND THE SCRUB TECH NOTICED THE SUTURE WAS NOT ATTACHED TO THE NEEDLE. THE SUTURE INFORMATION WAS NOTED AND LATER DISCARDED. A NEW SUTURE WAS OPENED TO COMPLETE THE PROCEDURE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SALES REP REPORTED THAT THE NEEDLE BROKE OFF THE SUTURE WHEN THE SURGEON USED IT. NEW ONE USED TO COMPLETE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1284246 SILK BLK 18IN 6-0 D/A G-6 PRM SUTURE, NONABSORBABLE, SILK GAP ETHICON INC. SEMLKT 10705031010451

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown