BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERSILK 3/0 45CM26MM CT CVD

    MDR report key: 12271679 · Received August 3, 2021

    Report

    Report Number
    2210968-2021-06974
    Event Type
    Malfunction
    Date Received
    August 3, 2021
    Date of Event
    July 8, 2021
    Report Date
    November 10, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAP
    PMA / PMN Number
    K946173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(6). DATE SENT TO THE FDA: 11/10/2021. H6 COMPONENT CODE: G07002 - PHOTO REVIEW. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. H3 INVESTIGATION: ACCORDING TO THE INFORMATION RECEIVED IT WAS REPORTED THAT SUTURE BROKE DURING SEWING SCALP IN UNKNOWN SURGERY. THE PRODUCT WAS NOT RETURNED FOR EVALUATION. VISUAL INSPECTION WAS CONDUCTED ON PICTURES RECEIVED. VISUAL ANALYSIS OF THE PICTURE RECEIVED DETERMINED THAT A NEEDLE-SUTURE COMBINATION ON A FOLDER OF PRODUCT LOT RD211 COULD BE OBSERVED. THE CONDITION REPORTED COULD NOT BE OBSERVED IN THE PICTURE. SAME BATCH MANUFACTURER RETAINED SAMPLE EVALUATED FOR APPEARANCE AND TENSILE STRENGTH AND NO ISSUE FOUND. DHR REVIEWED AND NO ISSUE FOUND. THE ROOT CAUSE OF THIS COMPLAINT CAN¿T BE DETERMINED, THIS COMPLAINT DATA WILL BE KEPT FOR TREND ANALYSIS. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT WAS NOT RETURNED FOR EVALUATION. VISUAL INSPECTION WAS CONDUCTED ON THREE PICTURES RECEIVED. VISUAL ANALYSIS OF THE PICTURE RECEIVED DETERMINED THAT A NEEDLE-SUTURE COMBINATION ON A FOLDER OF PRODUCT CODE W251101 COULD BE OBSERVED. THE CONDITION REPORTED COULD NOT BE OBSERVED IN THE PICTURE. THE MANUFACTURING RECORDS COULDN'T BE REVIEWED AS THE BATCH NUMBER IS UNKNOWN. NO CONCLUSION COULD BE REACHED AS TO WHAT CAUSED THE REPORTED COMPLAINT SINCE THE SAMPLE WAS NOT RETURNED FOR ANALYSIS. IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, EACH BATCH IS RANDOMLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. THE MANUFACTURING RECORDS COULDN'T BE REVIEWED AS THE BATCH NUMBER IS UNKNOWN. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1164580 MERSILK 3/0 45CM26MM CT CVD SUTURE, NONABSORBABLE, SILK GAP ETHICON INC. RD211

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown