BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILK SUTURE

    MDR report key: 16624714 · Received March 27, 2023

    Report

    Report Number
    2210968-2023-02114
    Event Type
    Malfunction
    Date Received
    March 27, 2023
    Date of Event
    January 1, 2023
    Report Date
    January 25, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAP
    PMA / PMN Number
    K946173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4) DATE SENT TO THE FDA: 4/21/2023 ADDITIONAL INFORMATION: D4, H3, H4, H6 A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. A DEVICE HAS BEEN RECEIVED FOR PRODUCT CODE NW5000, LOT V1010 HOWEVER IS HAS NOT YET BEEN EVALUATED. ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. 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. RELATED REPORTS: MW# 2210968-2023-02112, MW # 2210968-2023-02113, MW # 2210968-2023-02114, MW # 2210968-2023-02115, MW # 2210968-2023-02116, MW # 2210968-2023-02117, MW #2210968-2023-02118 PRODUCT COMPLAINT # PC-001307847 DATE SENT TO THE FDA: 4/21/2023 CORRECTED INFORMATION: D1 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 · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 1/25/2024. RETAIN SAMPLE EVALUATION: 02 DZS (24EA) OF RETAIN SAMPLES OF INCIDENT CODE NW5000 AND LOT NUMBER V1010 WERE RETRIEVED FOR ANALYSIS. THE DISPENSER BOX (OUTER BOX) OF RETAIN SAMPLES WERE VISUALLY INSPECTED FOR ATTRIBUTE DEFECTS LIKE FOREIGN MATTER, COLOR VARIATION, PRESENCE OF MOISTURE, DAMAGED PACK AND PRESS MARKS ON PACK BUT NO SUCH DEFECTS WERE OBSERVED. UPON FURTHER OPENING OF RETAIN SAMPLE DISPENSER BOXES THE PRIMARY PACKS OF RETAIN SAMPLES WERE VISUALLY INSPECTED FOR ATTRIBUTE DEFECTS LIKE PSEUDO SEAL, PIN HOLE, PRODUCT IN SEAL, PRESS MARKS ON PACK, FOREIGN MATTER BUT NO SUCH DEFECTS WERE OBSERVED. ALL THE 24 UNITS WERE FOUND TO BE FREE FROM FOREIGN MATTER. 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. FINISHED GOOD RECORD WAS REVIEWED FOR TENSILE STRENGTH VALUE AND NEEDLE PULL-OFF VALUE AT RELEASE AND FOUND TO MEET THE SPECIFICATION. FROM THE BATCH CARD REVIEW, IT WAS OBSERVED THAT THERE WAS NO ISSUE RELATED TO THE SUTURE PROCESSING OF THIS INCIDENT LOT. COMPLAINT SAMPLE EVALUATION: ACCORDING TO THE INFORMATION RECEIVED, FUNGAL GROWTH HAS BEEN OBSERVED INSIDE THE SUTURES. THE PRODUCT WAS RETURNED TO ETHICON FOR EVALUATION. VISUAL INSPECTION EVALUATION WAS CONDUCTED ON THE RETURNED DEVICE. THE RETURNED SAMPLE DETERMINED THAT SIX SEALED PACKETS AND ONE OPENED SAMPLE THAT PERTAIN TO PRODUCT CODE NW5000 WERE RETURNED TO ETHICON FOR ANALYSIS. UPON VISUAL ANALYSIS OF THE RETURNED SAMPLE, A BLACK FOREIGN MATTER THAT APPEARS TO BE MILDEW COULD BE OBSERVED INTO THE SAMPLES. NO CONCLUSION COULD BE REACHED AS TO WHAT CAUSED THE REPORTED COMPLAINT. THIS REPORT IS NOT INTENDED TO DENY THAT YOU EXPERIENCED A PROBLEM WITH THE DEVICE. THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT WE WERE UNABLE TO DUPLICATE DURING OUR LABORATORY ANALYSIS. THE REPORTED INCIDENT IS ONE AND ISOLATED CASE FOR CODE NW5000/LOT V1010. NO OTHER EVENT WAS REPORTED FOR SAME DESCRIPTION FROM OTHER PARTS OF COUNTRY WHERE THIS LOT WAS DISTRIBUTED. BASED ON THE ANALYSIS THIS IS NOT A CONFIRMED COMPLAINT. AS PART OF ETHICON QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE. CONSIDERING ABOVE INVESTIGATION ADEQUATE TO ADDRESS THE REPORTED COMPLAINT, THIS COMPLAINT IS RECOMMENDED FOR CLOSURE APPROVAL. 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. RELATED REPORTS: 2210968-2023-02112, 2210968-2023-02113, 2210968-2023-02114, 2210968-2023-02115, 2210968-2023-02116, 2210968-2023-02117, & 2210968-2023-02118.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). COMPONENT CODE: G07002 - DEVICE NOT RETURNED 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. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: COULD YOU PLEASE CLARIFY IF THE DEVICES WAS USED ON THE PATIENT? THE DEVICE WAS NOT USED ON THE PATIENT WAS THERE ANY PATIENT SIGN OR CONSEQUENCES DUE TO THE ISSUE? THE DEVICE WAS NOT USED ON THE PATIENT WHAT IS THE LOT NUMBER? OT NO -V1010 EVENT RELATED TO MW # 2210968-2023-02112, MW # 2210968-2023-02113, MW # 2210968-2023-02115, MW # 2210968-2023-02116, MW # 2210968-2023-02117, MW #2210968-2023-02118 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, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2023 THAT FUNGAL GROWTH HAD BEEN OBSERVED INSIDE THE SUTURES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472361 SILK SUTURE SUTURE, NONABSORBABLE, SILK GAP ETHICON INC. V1010

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown