BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHILON 2-0 45MM 70CM

    MDR report key: 14374101 · Received May 12, 2022

    Report

    Report Number
    2210968-2022-03633
    Event Type
    Malfunction
    Date Received
    May 12, 2022
    Date of Event
    April 20, 2022
    Report Date
    June 7, 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

    (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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WHAT TISSUE WAS BEING APPROXIMATED/ SUTURED? WAS THE PROCEDURE COMPLETED SUCCESSFULLY? WAS THERE ANY ADVERSE PATIENT OUTCOME? PATIENT CONDITION? WHAT WAS USED TO COMPLETE THE PROCEDURE? PROCEDURE NAME AND DATE? EVENT DATE? A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. EVENT RELATED TO MW # 2210968-2022-03632.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 6/7/2022. H6 COMPONENT CODE: G07002 NO DEVICE PROBLEM FOUND. ADDITIONAL INFORMATION WAS REQUESTED, THE FOLLOWING WAS OBTAINED: 1) WHAT TISSUE WAS BEING APPROXIMATED/ SUTURED? SKIN CLOSURE. 2) WAS THE PROCEDURE COMPLETED SUCCESSFULLY? YES, PROCEDURE WAS COMPLETED USING NEW SUTURE. 3) WAS THERE ANY ADVERSE PATIENT OUTCOME? NO . 4) PATIENT CONDITION? STABLE. 5) WHAT WAS USED TO COMPLETE THE PROCEDURE? NEW FOIL OF NW3336 SUTURE WAS USED. 6) PROCEDURE NAME AND DATE? OPEN REDUCTION DATE 20TH APRIL 2022. 7) EVENT DATE? 20TH APRIL 2022. 8 ) DEVICE RETURN STATUS? SAMPLE RECEIVED. POST EVALUATION AND SHIPMENT RMAO WILL BE UPDATED. H3 INVESTIGATIONAL SUMMARY: COMPLAINT SAMPLE: 02 OPENED UNIT OF COMPLAINT SAMPLE RECEIVED FOR INVESTIGATION; THE COMPLAINT SAMPLE CONSIST OF TWO OPEN SBF FOLDER, OVERWRAP, SUTURE AND NEEDLE FOR CODE NW3336 LOT V1084. 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, SUTURE 1) OPEN END OF SUTURE WAS VISUALLY INSPECTED AND IT HAS BEEN OBSERVED THAT THE SUTURE MIGHT HAVE COME INTO A CONTACT WITH SHARP OBJECT AND GOT CUT. SUTURE 2) THE SURFACE OF SUTURE WAS FOUND TO BE ROUGH WHICH INDICATED THAT THE SUTURE WAS HANDLED WITH FORCE OR KEPT ABOVE TEMPERATURE EXCEEDING CONDITION. RETURNED NEEDLE WAS VISUALLY INSPECTED AND FOUND SATISFACTORY. BATCH RECORD REVIEW: AS A PART OF FURTHER INVESTIGATION BATCH MANUFACTURING RECORD WAS REVIEWED FOR CODE NW3336 LOT V1084. 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 V1084 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 24.63 N AND VALUE AT THE TIME OF FINISHED GOOD RELEASE WAS FOUND TO BE 25.21 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 V1084. 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 BROKE AFTER PULLING IT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2381977 ETHILON 2-0 45MM 70CM SUTURE, NONABSORBABLE, SYNTHETIC GAR ETHICON INC. V1084

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown