BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NON ABSORBABLE SURGICAL SUTURE

    MDR report key: 19234622 · Received May 2, 2024

    Report

    Report Number
    2210968-2024-05069
    Event Type
    Malfunction
    Date Received
    May 2, 2024
    Date of Event
    April 16, 2024
    Report Date
    May 2, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAQ
    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). ADDITIONAL INFORMATION: H6 COMPONENT CODE: G07002 - DEVICE NOT RETURNED. ADDITIONAL INFORMATION PROVIDED: THEY GOT A PATIENT FOR HOSPITAL AND PLANNED CABG ( CORONARY ARTERY BYPASS GRAFT). DOCTOR (DR. (B)(6)) DECIDED THE SURGERY ON DATE: (B)(6) 2024 (TUESDAY).DURING SURGERY UNFORTUNATELY NEEDLE OF SUTURE WAS CUT AT TIME OF STERNUM CLOSURE. WHILE KNOTTING THE SUTURE WAS DAMAGED. AFTER THAT GONE FOR NEW BOX AND PROCEDURE WAS DONE. THE DELAY WAS HAPPENED FOR 5-10 MINUTES BECAUSE OF THE SUTURE COMPLIANT. THE DAMAGE SUTURE WAS TAKEN AND KEPT ASIDE (SUTURE CODE) AND INFORMED TO THE SALES TEAM ON (DATE) AND HANDED OVER DAMAGE SUTURE (CODE)AND REQUESTED TO DO THE NEEDFUL PLEASE FIND THE BELOW DETAILS SURGERY DATE: 16.04.2024 5PM (INFORMED). PRODUCT CODE:- MNW 9454 - 4 (FOIL). LOT NO -V 2005. EXPIRY DATE:- 01/2027. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NOT RECEIVED. ATTEMPTS TO OBTAIN THE DEVICE HAVE BEEN MADE. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. - WERE THERE ANY UNEXPECTED OUTCOMES OR COMPLICATIONS AS A RESULT OF THE PROLONGED SURGERY TIME? - WHAT TISSUE WAS BEING SUTURED WHEN THE EVENT OCCURRED? - WAS ADDITIONAL DISSECTION REQUIRED IN OTHER ORGANS/TISSUES OTHER THAN THE TARGET TISSUE? - WAS THERE ANY CHANGE IN THE PATIENT¿S POST OPERATIVE CARE DUE TO THE PROLONGED PROCEDURE? - PLEASE PERFORM AND DOCUMENT THE FOLLOW UP ATTEMPT FOR PRODUCT RETURN. PLEASE DOCUMENT THE SHIPMENT TRACKING NUMBER IN NOTES OR RMAO SECTIONS. - PLEASE PROVIDE THE SOURCE OR NAME OF PERSON PROVIDING ANSWERS TO FOLLOW-UP QUESTIONS (NOT THE PERSON RELAYING/SUBMITTING ANSWERS TO LOC OR CHU). IT WAS REPORTED THAT "NEEDLE OF SUTURE WAS CUT AT THE TIME OF STERNUM CLOSER". PLEASE CONFIRM WHICH OF THE FOLLOWING OCCURRED: * WAS THE NEEDLE BROKEN? * WAS THE SUTURE THREAD BROKEN? * DID THE NEEDLE PULL OFF FROM THE SUTURE THREAD? * IF THE NEEDLE WAS BROKEN, DID ANY PIECE FALL INTO THE PATIENT'S BODY? * WAS ANY ADDITIONAL INTERVENTION PERFORMED TO SEARCH FOR THE NEEDLE? A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED, AND NO RELATED NON-CONFORMANCES WERE IDENTIFIED. NOTE: EVENTS REPORTED ON MW# 2210968-2024-05066, MW# 2210968-2024-05067, AND MW# 2210968-2024-05068. 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.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 6/12/2024. H6 COMPONENT CODE: G07002 NO DEVICE PROBLEM FOUND. ADDITIONAL INFORMATION: D9, H3, H6. H3 INVESTIGATIONAL SUMMARY: THE PRODUCT WAS RETURNED TO ETHICON FOR EVALUATION. THE RETURNED PRODUCT DETERMINED THAT IT WAS RECEIVED, A SUTURE PIECE THAT PERTAINED TO PRODUCT CODE MNW9454. IN THE VISUAL ASSESSMENT OF THE SAMPLE, IT WAS NOTED THAT THE NEEDLE WAS NOT RETURNED FOR EVALUATION. ADDITIONALLY, THE SUTURE WAS EXAMINED, AND THE END WAS NOTED CUT PROBABLY CAUSED BY A SURGICAL INSTRUMENT. AS THE NEEDLE WAS NOT RETURNED, NO CONCLUSION COULD BE REACHED ON THE CAUSE OF THE REPORTED EVENT. AS PART OF THE 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. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED A PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFT PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING SURGERY UNFORTUNATELY NEEDLE OF SUTURE WAS CUT AT THE TIME OF STERNUM CLOSURE. AFTER THAT GONE FOR NEW BOX AND PROCEDURE WAS DONE. THE DELAY WAS HAPPENED FOR 5-10 MINUTES BECAUSE OF THE SUTURE COMPLAINT. NO ADVERSE EVENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458389 NON ABSORBABLE SURGICAL SUTURE SUTURE, NONABSORBABLE, STEEL GAQ ETHICON INC. V2005

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown