BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PDS II SUTURE 8-18" (45CM) 0 VIO

    MDR report key: 12869078 · Received November 24, 2021

    Report

    Report Number
    2210968-2021-12022
    Event Type
    Malfunction
    Date Received
    November 24, 2021
    Date of Event
    November 1, 2021
    Report Date
    November 24, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 12/29/2021. H6 COMPONENT CODE: G07002 - NO DEVICE PROBLEM FOUND. 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, 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. H3 EVALUATION: FOUR PACKETS OF PRODUCT CODE ZB776 WERE RETURNED FOR ANALYSIS WITH THE PACKAGING CLOSED. UPON INITIAL INSPECTION, OF THE SAMPLES, NO EXTERNAL DAMAGES WERE OBSERVED ON THE PACKETS. IN ORDER TO EVALUATE THE CONDITIONS OF THE RETURNED SAMPLES, THE PACKETS WERE OPENED, AND NO DEFECTS WERE DETECTED. THE SWAGE AND ATTACHMENT AREA WERE NOTED TO BE AS EXPECTED. THE SUTURES WERE DISPENSED WITHOUT PROBLEMS AND EXAMINED ALONG OF THE STRAND TO DETECT ANY ISSUE RELATED TO DAMAGED OR BREAKAGE SUTURE AND NO DEFECTS WERE OBSERVED DURING EVALUATION. FUNCTIONAL TEST WAS PERFORMED, AND THE TENSILE STRENGTH RESULT WERE ABOVE THE MINIMUM REQUIREMENTS. AS PART OF OUR QUALITY PROCESS, THE MANUFACTURING RECORDS OF THIS LOT-SERIAL NUMBER WERE REVIEWED, AND THE MANUFACTURING STANDARDS WERE MET PRIOR TO THE RELEASE OF THIS BATCH. IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, EACH BATCH IS RANDOMLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. 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. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE.

    Additional Manufacturer Narrative · 0

    (B)(4). A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: "* IT IS STATED: """"SUTURE BREAKAGE OCCURRED IN A ROW"""". PLEASE CONFIRM HOW MANY SUTURES BROKE ON THIS ONE PATIENT DURING THIS SINGLE SURGICAL PROCEDURE? =>THE REPORTED QTY OF PRODUCT INVOLVED IS 6. * HOW WAS PROCEDURE SUCCESSFULLY COMPLETED? =>NO FURTHER INFORMATION IS AVAILABLE. * PLEASE PROVIDE THE RETURN STATUS OF THE DEVICE(S) AS IT HAS NOT BEEN RECEIVED FOR ANALYSIS. IF THE DEVICE HAS BEEN SHIPPED, PLEASE PROVIDE THE SHIPMENT TRACKING DETAILS. =>WE REGULARLY CONTACT WITH SALES REP ABOUT THE DEVICE RETURNING. NO FURTHER INFORMATION WILL BE PROVIDED." 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. EVENTS REPORTED VIA: 2210968-2021-12019, 2210968-2021-12020, 2210968-2021-12021, 2210968-2021-12022, 2210968-2021-12023, 2210968-2021-12024

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROTOMY PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE BREAKAGE OCCURRED IN A ROW DURING ABDOMINAL WALL CLOSURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1766593 PDS II SUTURE 8-18" (45CM) 0 VIO SUTURES - ABSORBABLE NEW ETHICON INC. LB6896

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown