BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NABS SUR SUT USP MERSILK* NW5085

    MDR report key: 11407416 · Received March 3, 2021

    Report

    Report Number
    2210968-2021-01945
    Event Type
    Malfunction
    Date Received
    March 3, 2021
    Date of Event
    February 10, 2021
    Report Date
    February 10, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAP
    PMA / PMN Number
    K946173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT TO THE FDA: 4/27/2021. 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. H6 COMPONENT CODE: G07002 ¿ CONFORMING DEVICE. ADDITIONAL H3 INVESTIGATION SUMMARY: FIVE RETAIN SAMPLES OF THE INCIDENT CODE AND LOT NUMBER WAS RETRIEVED FOR ANALYSIS. THESE PACKS OF RETAIN SAMPLES WERE VISUALLY INSPECTED FOR ATTRIBUTE DEFECTS LIKE PSEUDO SEAL, PIN HOLE, PRODUCT IN SEAL, PRESS MARKS ON PACK BUT NO SUCH DEFECTS WERE OBSERVED. THESE PACKS WERE OPENED AND SUTURES AND NEEDLES WERE FOUND INTACT. THE SUTURES WERE PHYSICALLY INSPECTED FOR ANY ATTRIBUTE DEFECTS LIKE KINKS, WEAK SPOTS, BROKEN PIECE, FRAY, BRITTLENESS, DETACHED NEEDLES BUT NO SUCH DEFECTS WERE OBSERVED. THE NEEDLES WERE INSPECTED FOR ANY ATTRIBUTE DEFECTS LIKE BEND, CRACKED BARREL, FINS BUT NO SUCH DEFECTS WERE OBSERVED. AS A PART OF FURTHER INVESTIGATION BATCH MANUFACTURING RECORD WAS REVIEWED. THE BATCH MANUFACTURING RECORD WAS REVIEWED FOR ANY PROCESS DEVIATION, BUT NO DEVIATION WAS OBSERVED. STERILIZATION RUN RECORD WAS REVIEWED AND FOUND TO BE AS PER REQUIREMENTS. FINISHED GOODS RECORD WAS REVIEWED FOR FG RELEASE PARAMETERS LIKE DIAMETER, TENSILE STRENGTH VALUE, NEEDLE PULL-OFF VALUE & EXTRACTABLE COLOR AT RELEASE AND WAS FOUND TO MEET THE SPECIFICATION. FROM THE ABOVE ANALYSIS IT IS EVIDENT THAT THERE WAS NO ISSUE RELATED TO THE SUTURE QUALITY AND PROCESSING OF THIS INCIDENT LOT. AS THE COMPLAINT IS RELATED TO SUTURE BREAKAGE , TENSILE STRENGTH TEST IS APPLICABLE & MEASURABLE PARAMETER. MINIMUM KNOT PULL TENSILE STRENGTH TEST VALUE OF RETAIN SAMPLE WAS FOUND. THE AVERAGE KNOT PULL TENSILE STRENGTH TEST VALUE MEETS THE USP AVERAGE TENSILE STRENGTH REQUIREMENT . ALL THE INDIVIDUAL TENSILE STRENGTH VALUES FOR RETAIN SAMPLE WERE FOUND MEETING USP AVERAGE SPECIFICATION REQUIREMENT. THIS ANALYSIS SHOWS THAT THERE WAS NO ISSUE RELATED TO PROCESSING OF THE LOT. ALL THE VALUES ARE WITHIN THE CONTROL LIMITS. BASED ON THE ANALYSIS THIS IS NOT A CONFIRMED COMPLAINT. (B)(4). DATE SENT TO THE FDA: 4/27/2021. 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). A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT B7022 AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS LOT. 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. WERE THERE ANY ADVERSE PATIENT CONSEQUENCES? WHAT TISSUE WAS BEING APPROXIMATED OR SUTURED WHEN IT BROKE? HOW WAS THE PROCEDURE COMPLETED? IF DIFFERENT FROM EVENT DATE, PLEASE PROVIDE PROCEDURE DATE? DEVICE RETURN STATUS/FOLLOW UP? NOTE: EVENTS REPORTED IN 2210968-2021-01944. 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 RECTUM PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON OPEN THE FOIL AND THE SUTURE BROKE AFTER THE FIRST BITE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300991 NABS SUR SUT USP MERSILK* NW5085 SUTURE, NONABSORBABLE, SILK GAP ETHICON INC. B7022

    Patients

    Seq Age Sex Outcome Treatment
    1