BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILK BLK 18IN 3-0 S/A X-1

    MDR report key: 14190208 · Received April 22, 2022

    Report

    Report Number
    2210968-2022-02907
    Event Type
    Malfunction
    Date Received
    April 22, 2022
    Date of Event
    March 25, 2022
    Report Date
    May 24, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAP
    UDI-DI
    10705031007062
    PMA / PMN Number
    K946173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED VIA: WAS THERE ANY ADVERSE CONSEQUENCE ASSOCIATED WITH THE PATIENT? PLEASE PROVIDE THE LOT NUMBER: WAS THERE 2 PATIENT EVENTS: PATIENT #1: MARCH 24 - SUTURE BREAKAGE POST OP AND PATIENT #2: MARCH 25 - SUTURE BREAKAGE INTRA-OP? IF YES, PLEASE PROVIDE ADDITIONAL INFORMATION FOR THE PATIENT FROM YESTERDAY THAT HAD THE SUTURE BREAK AFTER GETTING HOME: WHAT IS THE PROCEDURE NAME? WHAT IS THE PROCEDURE DATE? WAS THERE ANY MEDICAL OR SURGICAL INTERVENTION PERFORMED (PRODUCT REMOVED; RE-OPERATION; RE-CLOSURE; PRESCRIPTION MEDICATION)? IF SO, PLEASE SPECIFY. IF MEDICATION WAS REQUIRED, PLEASE CLARIFY IF IT WAS PRESCRIBED BY A PHYSICIAN. WHAT IS THE MOST CURRENT PATIENT STATUS? DEVICE RETURN STATUS: THE PHOTO OF ONE OF MY SUTURES I SENT LAST WEEK IS FROM MY MOST RECENT PURCHASE. I GUESS YOU CAN SEE THE LOT NUMBER. I DON¿T HAVE DATES OF SURGICAL USAGE BUT HAVE HAD ABOUT 10 CASES NOW WHERE THE SILK SUTURES HAVE COME OUT ON THEIR OWN AFTER AS SHORT AS ONE DAY. THERE HAVE NOT BEEN ANY COMPROMISING SITES BUT HAVING BEEN SUTURING WITH YOUR PRODUCT FOR OVER TWENTY YEARS, I¿M QUESTIONING QUALITY RIGHT NOW. I¿VE EVEN HAD THE SUTURES SNAP DURING KNOTTING. MY TECHNIQUE REMAINS THE SAME AND SINCE IT¿S BEEN MORE THAN FREQUENT, I¿M ASKING WHY. I¿M OPEN TO A PHONE CALL AS WELL- I HATE TYPING!! THANK YOU. 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 Manufacturer Narrative · 0

    (B)(4). DATE SENT TO THE FDA: 5/19/2022. 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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. A PHOTO UPON WHICH THIS MEDWATCH IS BASED HAS BEEN RECEIVED, HOWEVER, THE PHOTO EVALUATION IS NOT YET COMPLETE. ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT TO THE FDA: 5/24/2022 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. VISUAL ANALYSIS OF IMAGES SUBMITTED TO ETHICON FOR EVALUATION DETERMINED THAT A CLOSED OVERWRAP PACKET WITH PRODUCT CODE 632G COULD BE OBSERVED. IMAGE IS NOT CLEAR TO DETERMINE FAILURE MODE OR REPORTED CONDITION. AS PART OF OUR QUALITY PROCESS, MANUFACTURING RECORDS WERE REVIEWED FOR THIS LOT'S SERIAL NUMBER AND MANUFACTURING STANDARDS WERE MET PRIOR TO THE RELEASE OF THIS LOT. NO CONCLUSION COULD BE REACHED AS TO THE CAUSE OF THE REPORTED COMPLAINT, AS THE SAMPLE WAS NOT RETURNED FOR ANALYSIS. AS PART OF ETHICON'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL INFORMATION ABOUT COMPLAINTS IS TRACKED FOR POTENTIAL SAFETY SIGNALS THROUGH COMPLAINT TRENDS AS PART OF POST-MARKET SURVEILLANCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. POST OPERATIVELY, THE SUTURE BROKE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795813 SILK BLK 18IN 3-0 S/A X-1 SUTURE, NONABSORBABLE, SILK GAP ETHICON INC. 632G RHBBRD 10705031007062

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown