BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLENE SUT 30IN(75CM) 0 BLU

    MDR report key: 17256247 · Received July 5, 2023

    Report

    Report Number
    2210968-2023-04759
    Event Type
    Malfunction
    Date Received
    July 5, 2023
    Date of Event
    May 3, 2023
    Report Date
    August 16, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    UDI-DI
    10705031021051
    PMA / PMN Number
    K133356
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). H6 COMPONENT CODE: G07002 - 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. 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 VIA: WHAT IS THE TOTAL NUMBER OF PRODUCTS INVOLVED IN THIS EVENT? DID THE EVENT OCCUR DURING ONE OR MULTIPLE PATIENT PROCEDURES? MULTIPLE SEE ANSWER OF DISTRIBUTOR. WHAT IS THE TOTAL NUMBER OF PROCEDURES? IN TOTAL THREE. HAVE ANY OF THESE EVENTS BEEN PREVIOUSLY REPORTED TO ETHICON? IF SO, PROVIDE THE RESPECTIVE REFERENCE NUMBER(S). NONE , BUT TO NWE COMPLAINT CREATED IN ADDITION SEE (B)(4) FOR 10TH MAY (B)(4) FOR 24TH MAY IF THIS EVENT OCCURRED IN MULTIPLE PROCEDURES, PLEASE CREATE A PRODUCT COMPLAINT FOR EACH EVENT AND PROVIDE THE RESPECTIVE REFERENCE NUMBER(S). DID THE PULL OFF - SUTURE NEEDLE OCCUR? NO. IF YES, HOW MANY SUTURES ARE PULLED OFF? DID THE SUTURE BREAKAGE OCCUR? YES. IF YES, HOW MANY SUTURES ARE BROKEN? IN THREE PROCEDURES. WHAT IS THE TOTAL NUMBER OF EVENTS? THREE EVENTS. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. EVENTS REPORTED VIA: 2210968-2023-04757.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 8/16/2023. H6 COMPONENT CODE: G07002 NO DEVICE PROBLEM FOUND. H3 INVESTIGATIONAL SUMMARY: THE PRODUCT WAS RETURNED TO ETHICON FOR EVALUATION. VISUAL INSPECTION AND FUNCTIONAL TEST EVALUATION WERE CONDUCTED ON THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE DETERMINED THAT ONE OPENED BOX WITH TWENTY-SEVEN PACKETS BOX THAT PERTAINS TO PRODUCT CODE 8834H WAS RECEIVED FOR EVALUATION. IN ORDER TO EVALUATE THE CONDITIONS OF THE RETURNED SAMPLES, THIRTEEN 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 THE STRAND TO DETECT ANY ISSUE RELATED TO DAMAGED OR BREAKAGE SUTURES AND NO DEFECTS WERE OBSERVED DURING EVALUATION. A FUNCTIONAL TEST WAS PERFORMED, AND THE TENSILE STRENGTH RESULTS WERE ABOVE THE MINIMUM REQUIREMENTS. THE EVENT DESCRIBED COULD NOT BE CONFIRMED AS THE DEVICE PERFORMED WITHOUT ANY DEFECT NOTED. 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. 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. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS 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.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 7/5/2023. ADDITIONAL INFORMATION WAS REQUESTED, THE FOLLOWING WAS OBTAINED: DID 1 SUTURE BREAK IN EACH OF THE 3 PROCEDURES? MORE THAN ONE EXACT NUMBER IS UNKNOWN HOW MANY SUTURE BREAKAGES OCCURRED DURING THE PROCEDURE REPRESENTED IN (B)(4)? EXACT NUMBER IS UNKNOWN. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED: WE HAD HUMAN OP DAYS ON THE (B)(6) WHEN USING THE THREADS (SUTURES IN UMBILICAL AND INGUINAL HERNIA OPERATIONS), THREADS CONSTANTLY BROKE OFF WHEN PULLED AND HAD TO BE RENEWED. THIS IS UNTYPICAL FOR THIS TYPE OF SUTURE PROLENE 0, SINCE THIS SUTURE HAS ALWAYS BEEN USED FOR SEVERAL YEARS AND OTHERWISE SUTURES HAVE ALMOST NEVER BROKEN DURING MESH IMPLANTATION, SO WE ASSUME A MATERIAL DEFECT. RUPTURE OF THE SUTURE WHEN IT WAS PULLED OUT OF THE BODY WITH ONLY SLIGHT TRACTION." THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. 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: 2210968-2023-04757.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    990461 PROLENE SUT 30IN(75CM) 0 BLU SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC. 8834H RKBEEP 10705031021051

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown