BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHILON* BLK 2-0 45CM (1)SC-30

    MDR report key: 12465207 · Received September 13, 2021

    Report

    Report Number
    2210968-2021-08370
    Event Type
    Malfunction
    Date Received
    September 13, 2021
    Date of Event
    July 23, 2021
    Report Date
    November 19, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAR
    PMA / PMN Number
    K946173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 11/19/2021. H6 COMPONENT CODE: G07002 NO DEVICE PROBLEM FOUND. H3 INVESTIGATIONAL NARRATIVE: FOURTEEN PACKETS OF PRODUCT CODE 1215T WERE RETURNED TO ETHICON INC FOR ANALYSIS WITH THE PACKAGING CLOSED. UPON INITIAL INSPECTION TO THE SAMPLES NO EXTERNAL DAMAGES WERE OBSERVED ON THE PACKETS. 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 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. AS PART OF ETHICON QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE. ADDITIONAL H3 INVESTIGATION NARRATIVE: VISUAL ANALYSIS OF THE RETURNED PRODUCT REVEALED THAT ONE NEEDLE/SUTURE PIECE OF PRODUCT CODE 1215 WERE RECEIVED TO ETHICON INC FOR EVALUATION. UPON VISUAL INSPECTION OF THE RETURNED SAMPLE, THE END OF THE SUTURE WAS OBSERVED CUT. AFTER FURTHER EVALUATION CRIMPING MARKS WERE OBSERVED ON THE SURFACE SUTURE POSSIBLY FROM A SURGICAL INSTRUMENT AND FUNCTIONAL TEST CANNOT BE PERFORMED. AS WITH ANY DEVICE, CARE SHOULD BE TAKEN TO AVOID DAMAGE TO THE STRAND WHEN HANDLING. AVOID THE CRUSHING OR CRIMPING ACTION OF THE SURGICAL INSTRUMENTS, SUCH AS NEEDLE HOLDERS AND FORCEPS. 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. AS PART OF ETHICON QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. 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 · 1

    (B)(4). 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: WHAT TISSUE WAS BEING APPROXIMATED OR SUTURED WHEN IT BROKE? CLOSING THE SECOND PLANE OF THE ABDOMEN. WILL THE DEVICE BE RETURNED? IF YES, TO WHOM SHOULD A SHIPPER KIT BE SENT TO? IT WILL BE RETURNED. THE ADJUSTMENT OF THIS MATERIAL IS CARRIED OUT COMMERCIALLY, NOT REQUIRING SHIPMENT AT THE TIME. PER FILE "ADD INFO - RE EXTERNAL PC - (B)(4)" THE DISTRIBUTOR INFORMED THE FOLLOWING: "I FILED A COMPLAINT ABOUT THE THREAD AND AT THE TIME I WAS INFORMED THAT THERE WOULD BE 6 UNITS WITH A PROBLEM, HOWEVER THERE WERE 14 UNITS." A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCE'S WERE IDENTIFIED. EVENT RELATED TO: 210968-2021-08368, 2210968-2021-08369, 2210968-2021-08371, 2210968-2021-08372, 2210968-2021-08374, 2210968-2021-08375, AND 2210968-2021-08378. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. EVENTS REPORTED VIA: 2210968-2021-08358 AND 2210968-2021-08359.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABDOMINOPLASTY / LIPOSUCTION PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. AT THE END OF THE PROCEDURE, AS SOON AS "TYING THE KNOT" WHEN DOING THE STITCHES, IT BROKE. THE PROCEDURE WAS COMPLETED WITH THE SAME THREAD, BUT FROM A DIFFERENT LOT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1362862 ETHILON* BLK 2-0 45CM (1)SC-30 SUTURE, NONABSORBABLE, SYNTHETIC GAR ETHICON INC. AP3539

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown