BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHIBOND 2/0 TC D/A 17MM 75CM

    MDR report key: 23489987 · Received November 6, 2025

    Report

    Report Number
    2210968-2025-12575
    Event Type
    Malfunction
    Date Received
    November 6, 2025
    Date of Event
    October 14, 2025
    Report Date
    November 6, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4) 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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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: 3 X NON-STERILE (CONTAMINATED) SACHETS INCLUDING ALL BROKEN THREADS WITH NEEDLES ATTACHED. 6 X STERILE SACHETS (UNOPENED) FROM SAME BATCH. THE MANUFACTURING RECORDS COULD NOT BE REVIEWED AS THE BATCH/LOT NUMBER IS UNKNOWN. ADDITIONAL H11: WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO, IF YES, NUMBER OF MINUTES: NA, ACTION TAKEN WHEN EVENT OCCURRED? ADDITIONAL W10B54 SUTURES FROM A DIFFERENT BATCH WERE OPENED WHICH PERFORMED WITHOUT PROBLEM, WAS PROCEDURE SUCCESSFULLY COMPLETED? YES, WERE FRAGMENTS GENERATED? NO, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? YES, PATIENT STATUS/ OUTCOME / CONSEQUENCES NO, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? NONE, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: NO, IS THE PATIENT PART OF A CLINICAL STUDY UNKNOWN, (B)(4), DEVICE PROPERTY OF HOSPITAL, DEVICE IN POSSESSION OF (B)(6), (REP). "D4: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THEREFORE, (01) GTIN IS NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 12/12/2025. 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, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, 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. H6 COMPONENT CODE: G07002 NO DEVICE PROBLEM FOUND. ADDITIONAL INFORMATION: D9, H3, H6. H3 INVESTIGATIONAL SUMMARY: THE PRODUCT WAS RETURNED TO ETHICON FOR EVALUATION. ONE OPEN FOLDER PACKET WITH EIGHT UNDISPENSED STRANDS AND FOUR SMALL NEEDLE-SUTURE PIECES WAS RECEIVED FOR ANALYSIS. THE PRODUCT CODE, W10B54, IS MULTISTRAND AND CONTAINS TEN DOUBLE ARMED STRANDS PER PACKET. DURING THE INITIAL INSPECTION OF THE FOUR NEEDLE-SUTURE PIECES, NO BREAKAGE SUTURE WAS OBSERVED. EVEN THOUGH THE EXTREMES WERE NOTED TO BE CUT, THESE WERE LIKELY CAUSED BY A SURGICAL INSTRUMENT. FURTHERMORE, BODY FLUIDS WERE NOTED ALONG THE LENGTH OF THE SUTURE PIECES. THE FUNCTIONAL TEST WAS NOT POSSIBLE BECAUSE THE SUTURE WAS RECEIVED WITH A SHORT LENGTH. THE OTHER SECTIONS OF THE SUTURES WERE NOT RETURNED FOR ANALYSIS. THE EIGHT UNDISPENSED STRANDS WERE DISPENSED WITHOUT PROBLEMS AND EXAMINED ALONG THE STRAND TO DETECT ANY ISSUE RELATED TO THE CUSTOMER COMPLAINT AND NO DEFECTS WERE OBSERVED DURING EVALUATION. THE FUNCTIONAL TEST WAS PERFORMED USING INSTRON EQUIPMENT, AND THE PULL FORCE AND TENSILE STRENGTH WERE ABOVE THE MINIMUM REQUIREMENTS. GIVEN THE CURRENT CONDITION OF THE RETURNED SAMPLE, NO CONCLUSION COULD BE REACHED AS TO WHAT CAUSED THE REPORTED COMPLAINT. AS PART OF THE 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. H3 INVESTIGATIONAL SUMMARY: THE PRODUCT WAS RETURNED TO ETHICON FOR EVALUATION. ONE OPEN BOX WITH SIX (6) REPRESENTATIVE UNOPENED SAMPLES WAS RECEIVED FOR ANALYSIS. PRODUCT CODE W10B54. THE COMPLAINT SAMPLE WAS NOT RECEIVED FOR EVALUATION. UPON INITIAL INSPECTION OF THE SAMPLES, NO EXTERNAL DAMAGES WERE OBSERVED ON THE EXTERNAL PACKETS. IN ORDER TO EVALUATE THE CONDITION OF THE RETURNED SAMPLES, THE PACKETS WERE OPENED, AND 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 THE CUSTOMER COMPLAINT AND NO DEFECTS WERE OBSERVED DURING EVALUATION. THE FUNCTIONAL TEST WAS PERFORMED USING INSTRON EQUIPMENT AND THE TENSILE FORCE WAS ABOVE THE MINIMUM REQUIREMENTS. THE EVENT DESCRIBED COULD NOT BE CONFIRMED AS THE DEVICE PERFORMED WITHOUT ANY DEFECT NOTED. AS PART OF THE ETHICON QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE EVENT DESCRIBED COULD NOT BE CONFIRMED AS NO PRODUCT DEFECT WAS IDENTIFIED, THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT COULD NOT BE REPLICATED DURING THE LABORATORY ANALYSIS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A VALVE REPLACEMENT PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, DR S IS A CARDIO-THORACIC SGN WHO USES W10B54 REGULARLY AT ALL HIS HOSPITALS. HE ENCOUNTERED APPROXIMATELY 3-4 THREAD BREAKAGES WITH W10B54 LOT 1063UC (EXP 12/2029) WHILE KNOTTING. ALL BREAKAGES OCCURRED WITH THIS BATCH WHILE PERFORMING A VALVE REPLACEMENT. AS SOON AS HE USED THE SAME CODE FROM ANOTHER BATCH, HE HAD NO FURTHER BREAKAGES. "I HAVE IN MY POSSESSION 3 X OPEN W10B54 MULTI STRAND SACHETS WHICH HAVE NOT BEEN DISINFECTED, SHOWING SEVERAL CONTAMINATED BROKEN THREADS IN A SPECIMEN BUCKET. I ALSO HAVE WITH ME 6 X STERILE W10B54 MULTI STRAND SACHETS WHICH ARE UNOPENED SAMPLES FROM THE AFFECTED BATCH". NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2085292 ETHIBOND 2/0 TC D/A 17MM 75CM SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC. 1063UC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown