BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHILON 2-0 45MM 70CM

    MDR report key: 14187417 · Received April 22, 2022

    Report

    Report Number
    2210968-2022-02884
    Event Type
    Malfunction
    Date Received
    April 22, 2022
    Date of Event
    March 28, 2022
    Report Date
    August 4, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAR
    PMA / PMN Number
    K946173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (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/ SUTURED? SKIN CLOSER. WAS THE PROCEDURE COMPLETED SUCCESSFULLY? YES. WAS THERE ANY ADVERSE PATIENT OUTCOME? NO. 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: 5/23/2022 ADDITIONAL INFORMATION: D9, H3, H4, H6 H6 COMPONENT CODE: G07002 NO DEVICE PROBLEM FOUND A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. H3 INVESTIGATIONAL SUMMARY: COMPLAINT SAMPLE: 01 OPENED UNIT OF COMPLAINT SAMPLE RECEIVED FOR INVESTIGATION; THE COMPLAINT SAMPLE CONSIST OF ONE OPEN SBF FOLDER, PIECE OF SUTURE ATTACHED TO A NEEDLE FOR CODE NW3336 LOT T1082. AS THE COMPLAINT SAMPLE RECEIVED IN OPEN CONDITION FURTHER INVESTIGATION WAS NOT PERFORMED ON COMPLAINT SAMPLE EXCEPT VISUAL INSPECTION. RECEIVED SUTURE WAS VISUALLY INSPECTED AND CHECKED AGAINST MENTIONED VOC PERFORMANCE - BREAKAGE SUTURE BUT SAME WAS NOT EVIDENT. THE LENGTH OF A RECEIVED SUTURE WAS 77 CM¿S IN LENGTH, OTHER END OF SUTURE WAS FOUND SATISFACTORY, AND NO INDICATION OF SUTURE CUT, OR BREAKAGE WAS IDENTIFIED. RECEIVED NEEDLE WAS VISUALLY INSPECTED AND FOUND SATISFACTORY. COMPLAINT SAMPLE FOIL WAS NOT RECEIVED FOR INVESTIGATION. BATCH RECORD REVIEW: AS A PART OF FURTHER INVESTIGATION BATCH MANUFACTURING RECORD WAS REVIEWED FOR CODE NW3336 LOT V1082. THE BATCH MANUFACTURING RECORD WAS REVIEWED FOR ANY PROCESS DEVIATION, BUT NO DEVIATION WAS OBSERVED. FINISHED GOOD RECORD WAS REVIEWED FOR TENSILE STRENGTH VALUE AND NEEDLE PULL-OFF VALUE AT RELEASE AND FOUND TO MEET THE SPECIFICATION. FROM THE BATCH RECORD REVIEW, IT HAS BEEN OBSERVED THAT THERE WAS NO ISSUE RELATED TO THE SUTURE QUALITY AND PROCESSING OF THIS INCIDENT LOT. RETAIN SAMPLE: FIVE RETAIN SAMPLES OF INCIDENT CODE NW3336 LOT V1082 WERE RETRIEVED FOR ANALYSIS. THE PRIMARY PACKS OF RETAIN SAMPLES WERE VISUALLY INSPECTED FOR ATTRIBUTE DEFECTS LIKE PSEUDO SEAL, PIN HOLE, PRODUCT IN SEAL, PRESS MARKS ON PACK BUT NO SUCH DEFECTS WERE OBSERVED. THE PRIMARY PACKS WERE OPENED, AND SUTURES AND NEEDLES WERE FOUND INTACT. THE SUTURES WERE PHYSICALLY INSPECTED FOR ANY ATTRIBUTE DEFECTS LIKE KINKS, WEAK SPOTS, BROKEN PIECE, FRAY, BRITTLENESS, DETACHED NEEDLES BUT NO SUCH DEFECTS WERE OBSERVED. THE NEEDLES WERE INSPECTED FOR ANY ATTRIBUTE DEFECTS LIKE BEND, CRACKED BARREL, FINS BUT NO SUCH DEFECTS WERE OBSERVED. THE RETAIN SAMPLES WERE TESTED FOR KNOT PULL TEST AND FOUND TO MEET THE SPECIFICATION. AS THE COMPLAINT IS RELATED TO PERFORMANCE-BREAKAGE SUTURE, KNOT PULL TENSILE STRENGTH TEST IS APPLICABLE & MEASURABLE PARAMETER. KNOT PULL TENSILE STRENGTH TEST WAS PERFORMED OVER FIVE RETAIN SAMPLES TO CHECK THE BEHAVIOR OF THE SUTURE MATERIAL. THE AVERAGE KNOT PULL TENSILE STRENGTH VALUE OF THE RETAIN SAMPLE WAS FOUND TO BE 23.98 N AND VALUE AT THE TIME OF FINISHED GOOD RELEASE WAS FOUND TO BE 21.53 N WHICH MEETS THE USP AVERAGE KNOT PULL TENSILE STRENGTH REQUIREMENT I.E. NLT 14.10 N. ALL THE INDIVIDUAL AS WELL AS AVERAGE KNOT PULL TENSILE STRENGTH VALUES OF RETAIN SAMPLE FOUND TO MEET THE USP SPECIFICATION REQUIREMENTS. THIS ANALYSIS SHOWS THAT THERE WAS NO ISSUE RELATED TO PROCESSING OF THE LOT. ALL THE VALUES ARE WITHIN THE CONTROL LIMITS. THE REPORTED INCIDENT WAS ONE AND ISOLATED CASE FOR CODE NW3336 LOT V1082. NO OTHER EVENT WAS REPORTED FOR SAME DESCRIPTION FROM OTHER PARTS OF COUNTRY. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE SUTURE WAS BROKEN IN BETWEEN SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795650 ETHILON 2-0 45MM 70CM SUTURE, NONABSORBABLE, SYNTHETIC GAR ETHICON INC. V1082

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown