BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 14196448 · Received April 25, 2022

    Report

    Report Number
    2210968-2022-02941
    Event Type
    Malfunction
    Date Received
    April 25, 2022
    Date of Event
    January 1, 2022
    Report Date
    June 2, 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

    (B)(4). 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: (B)(6) - SUTURE BREAKAGE POST OP AND PATIENT #2: (B)(6) - 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. 7. REMEDIAL "ACTN" INITIATED "OTHR" TYPE 2ND.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT NUMBER: (B)(4). DATE SENT TO THE FDA: 6/2/2022. H6 COMPONENT CODE: G07002: DEVICE NOT RETURNED. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. PART 4 SUBPART B. 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: H4, H6. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2022 AND SUTURE WAS USED. DURING THE SURGERY, THE SUTURE BROKE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742262 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