BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NON ABSORBABLE SURGICAL SUTURE

    MDR report key: 13826712 · Received March 19, 2022

    Report

    Report Number
    2210968-2022-01920
    Event Type
    Malfunction
    Date Received
    March 19, 2022
    Date of Event
    February 19, 2022
    Report Date
    April 28, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    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 VIA: QUES- WAS THERE ANY ADVERSE CONSEQUENCE ASSOCIATED WITH THE PATIENT? ANS- NO. QUES- WAS THERE ANY CHANGE IN THE PATIENT¿S POST-OPERATIVE CARE DUE TO THE PROLONGED PROCEDURE? ANS- NO. QUES- WERE THERE ANY UNEXPECTED OUTCOMES OR COMPLICATIONS AS A RESULT OF THE PROLONGED SURGERY TIME? ANS- NO. QUES- DID THE NEEDLE FALL INTO THE PATIENT? ANS- NO. QUES- DEVICE RETURN STATUS. ANS- NOT AVAILABLE. PHOTO ANALYSIS: TWO PHOTOS FOR REVIEW SHOWING A LABELED WINDING FORMER AND TWO NEEDLES OF PRODUCT CODE NW825. THE NEEDLES WERE OBSERVED WITH USE, BODILY FLUIDS, MARKS, DISTORTED IN THE ORIGINAL CURVATURE AND BROKEN AT THE POINT OF THE NEEDLE. AS PART OF OUR QUALITY PROCESS, MANUFACTURING RECORDS FOR THIS BATCH SERIAL NUMBER WERE REVIEWED AND MANUFACTURING STANDARDS WERE MET PRIOR TO THE RELEASE OF THIS BATCH. NO CONCLUSION COULD BE REACHED ON THE CAUSE OF THE REPORTED COMPLAINT, AS THE SAMPLE WAS NOT RETURNED FOR ANALYSIS. AS PART OF QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. EVENTS REPORTED VIA: 2210968-2022-01921.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 4/28/2022. H6 COMPONENT CODE: G07002 NO DEVICE PROBLEM FOUND. H3 INVESTIGATIONAL SUMMARY: COMPLAINT SAMPLE:(PHOTO) 2 PHOTOGRAPHS OF FOR CODE NW825 LOT V0002 WERE PROVIDED FOR INVESTIGATION. UPON PRELIMINARY PHOTOGRAPHIC EVALUATION OF PHOTOGRAPH 1 PRODUCT ARTWORK WAS FOUND TO BE GENUINE ETHICON AURANGABAD INDIA MANUFACTURED PRODUCT. PHOTOGRAPH 1: CONSISTS OF COMPLAINT SAMPLE ZIPPER TRAY AND LID FOR CODE NW825 LOT V0002, SUTURE AND NEEDLE WAS NOT PRESENT IN PHOTOGRAPH. PHOTOGRAPH 2: CONSIST OF 2 BROKEN PIECES OF NEEDLE WITH SMALL SUTURE PIECES ATTACHED TO ONE END COMPLAINT SAMPLE FOIL AND PRODUCT IDENTIFIERS WERE NOT PRESENT IN PHOTOGRAPH. NEEDLE PIECES WERE VISUALLY INSPECTED BROKEN NEEDLE PIECE WAS OBSERVED TO BE BENT AT BROKEN END HOWEVER, IN ABSENCE OF PHYSICAL COMPLAINT SAMPLE IT CANNOT BE DETERMINED THAT WHAT HAD CONTRIBUTED THE FAILURE OF THE DEVICE. RETAIN SAMPLE ANALYSIS: FIVE RETAIN SAMPLES OF THE NEEDLES FOR MRN VQ30050001. WERE RETRIEVED FOR ANALYSIS. THE NEEDLE RETAIN SAMPLES WERE VISUALLY INSPECTED FOR PHYSICAL APPEARANCE LIKE CURVATURE, POINT, LENGTH ETC. ATTRIBUTE DEFECTS SUCH AS BEND, CRACKED BARREL AND WERE FOUND SATISFACTORY. BORE DIAMETER, WIRE DIAMETER AND BORE DEPTH TEST RESULTS WERE FOUND TO BE MEETING SPECIFICATION REQUIREMENT. NO DEFECTS WERE OBSERVED IN THE RETAIN SAMPLE. THESE RETAIN SAMPLES WERE TESTED FOR % STIFFNESS & DUCTILITY AND FOUND TO MEET SPECIFICATION. AS THE COMPLAINT IS RELATED TO PERFORMANCE - BREAKAGE NEEDLE, STIFFNESS AND DUCTILITY TEST ARE APPLICABLE & MEASURABLE PARAMETERS. STIFFNESS TEST WAS PERFORMED TO CHECK THE BEHAVIOR OF THE NEEDLE MATERIAL AND PROCESS CONTROL. FOR MRN VQ30050001THE INDIVIDUAL MIN % STIFFNESS TEST VALUE OF THE RETAIN SAMPLE WAS FOUND TO BE 57% WHICH MEETS IN-HOUSE REQUIREMENT OF IND. MIN I.E. NLT 54 %. ALL INDIVIDUAL STIFFNESS VALUES WERE FOUND TO BE ABOVE INDIVIDUAL MINIMUM IN-HOUSE REQUIREMENT FOR STIFFNESS TEST. FURTHER DUCTILITY TEST WAS PERFORMED TO CHECK THE BEHAVIOR OF THE NEEDLE MATERIAL AND PROCESS CONTROL. FOR MRN VQ30050001 THE AVERAGE DUCTILITY TEST VALUES OF THE RETAIN SAMPLES WAS FOUND TO BE 2.2 WHICH MEETS IN-HOUSE REQUIREMENT INDIVIDUAL MINIMUM REQUIREMENT I.E. NLT 1.5. ALL THE INDIVIDUAL % STIFFNESS VALUES & DUCTILITY TEST VALUES WERE FOUND TO BE MEETING INDIVIDUAL IN-HOUSE REQUIREMENT. THE ABOVE ANALYSIS SHOWS THAT THERE WAS NO ISSUE RELATED TO PROCESSING OF THE LOT. ALL THE VALUES ARE WITHIN THE CONTROL LIMITS. BASED ON THE ABOVE INVESTIGATION THIS IS NOT A CONFIRMED COMPLAINT. CONSIDERING ABOVE INVESTIGATION ADEQUATE TO ADDRESS THE REPORTED COMPLAINT, THIS COMPLAINT IS RECOMMENDED FOR CLOSURE APPROVAL. 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 A GASTROJEJUNOSTOMY PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10844 NON ABSORBABLE SURGICAL SUTURE SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC. V0002

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown