BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHLN BLK 18IN 6-0 S/A SC-16

    MDR report key: 16708953 · Received April 10, 2023

    Report

    Report Number
    2210968-2023-02546
    Event Type
    Malfunction
    Date Received
    April 10, 2023
    Date of Event
    January 1, 2023
    Report Date
    August 16, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAR
    PMA / PMN Number
    K946173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 4/10/2023. H6 COMPONENT CODE: C22 - PHOTO ANALYSIS. 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. ADDITIONAL INFORMATION WAS REQUESTED, THE FOLLOWING WAS OBTAINED: IF THIS EVENT OCCURRED IN MULTIPLE PROCEDURES, PLEASE CREATE A PRODUCT COMPLAINT FOR EACH EVENT AND PROVIDE THE RESPECTIVE REFERENCE NUMBER(S). DEVICE RETURN STATUS. PLEASE DOCUMENT THE SHIPMENT TRACKING NUMBER: OCCURRED PRE-OP, BUT THE EVENT DESCRIPTION IS SOMEWHAT AMBIGUOUS AS TO WHEN THE ISSUE ACTUALLY OCCURRED. WHEN WAS THE SUTURES ¿CUT AND DO NOT TOLERATE THE TENSION¿ (IN THE PACKAGE, DURING REMOVAL FROM PACKAGE, DURING HANDLING PRIOR TO USE ON PATIENT OR DURING USE ON THE PATIENT)? SORRY, IT WAS DURING THE SURGERY. DID ANY OF THESE 24 SUTURES BREAK DURING SURGERY? YES, I HAVE A VIDEO. DID THE EVENT OCCUR DURING ONE OR MULTIPLE PATIENT PROCEDURES? ONLY ONE. WHAT IS THE TOTAL NUMBER OF PROCEDURES? ONE. HAVE ANY OF THESE EVENTS BEEN PREVIOUSLY REPORTED TO ETHICON? NO. THE FOLLOWING INFORMATION WAS RECEIVED: DID THE EVENT OCCUR DURING STERILE PROCESSING? UNKNOWN, DID THE EVENT OCCUR DURING FIELD INSPECTION? UNKNOWN, DID THE EVENT OCCUR DURING INTERNAL SERVICE ACTIVITIES SUCH AS CALIBRATION? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN. 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. PHOTO ANALYSIS: THIS IS AN ANALYSIS FOR A PHOTO SUBMITTED TO ETHICON FOR EVALUATION. DURING THE VISUAL ANALYSIS, THE FOLLOWING WAS OBSERVED: THE VIDEO SHOWS THE SURGEON APPLYING FORCE TO THE SUTURE IN SEVERAL SECTIONS. THE VIDEO IS NOT CLEAR TO DETERMINE THE FAILURE MODE. BASED ON THE VIDEO REVIEW, THE EVENT DESCRIBE IS CONFIRMED, HOWEVER NO CONCLUSION OR ROOT CAUSE COULD BE DETERMINED. HANDS ON DEVICE ANALYSIS MAY PROVIDE THE ADDITIONAL EVIDENCE NECESSARY TO CONFIRM THE ROOT CAUSE OF THE REPORTED EVENT. BECAUSE THE INSTRUMENT WAS NOT RETURNED OUR EVALUATION IS LIMITED. WE VALUE THE OPPORTUNITY TO FULLY ANALYZE THE INSTRUMENT UPON ITS RETURN. AS PART OF ETHICON QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST MARKET SURVEILLANCE. RELATED REPORTS: 2210968-2023-02543, 2210968-2023-02544, 2210968-2023-02533, 2210968-2023-02545, 2210968-2023-02547, 2210968-2023-02548, 2210968-2023-02549, 2210968-2023-02550, 2210968-2023-02551, 2210968-2023-02552, 2210968-2023-02553, 2210968-2023-02554, 2210968-2023-02555, 2210968-2023-02556, 2210968-2023-02559, 2210968-2023-02560, 2210968-2023-02561, 2210968-2023-02562, 2210968-2023-02563, 2210968-2023-02564, 2210968-2023-02565, 2210968-2023-02566, & 2210968-2023-02567.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 8/16/2023. H6 COMPONENT CODE: G07002 NO DEVICE PROBLEM FOUND. H3 INVESTIGATIONAL SUMMARY: THE PRODUCT WAS RETURNED TO ETHICON FOR EVALUATION. VISUAL INSPECTION AND FUNCTIONAL TESTING WERE CONDUCTED ON THE RETURNED DEVICE. THE RETURNED SAMPLES DETERMINED THAT IT WAS RECEIVED ELEVEN UNOPENED SAMPLES THAT PERTAIN TO THE PRODUCT CODE 160T. IN ORDER TO EVALUATE THE CONDITION OF THE RETURNED SAMPLES, THE PACKETS WERE OPENED, AND THE SWAGE AND ATTACHMENT AREA WAS NOTED TO BE AS EXPECTED. THE SUTURES WERE DISPENSED WITHOUT PROBLEMS AND EXAMINED ALONG THE STRAND AND NO ISSUES RELATED TO BREAKAGE SUTURES OR ANOMALIES WERE OBSERVED DURING THE EVALUATION. A FUNCTIONAL TEST WAS PERFORMED USING INSTRON EQUIPMENT AND THE TENSILE FORCE WAS ABOVE THE MINIMUM REQUIREMENTS. 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. RELATED REPORTS: 2210968-2023-02543, 2210968-2023-02544, 2210968-2023-02533, 2210968-2023-02545, 2210968-2023-02546, 2210968-2023-02547, 2210968-2023-02548, 2210968-2023-02549, 2210968-2023-02550, 2210968-2023-02551, 2210968-2023-02552, 2210968-2023-02553, 2210968-2023-02554, 2210968-2023-02555, 2210968-2023-02556, 2210968-2023-02559, 2210968-2023-02560, 2210968-2023-02561, 2210968-2023-02562, 2210968-2023-02563, 2210968-2023-02564, 2210968-2023-02565, 2210968-2023-02566, AND 2210968-2023-02567.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THE DOCTOR REPORTS THAT THE SUTURES ¿CUT AND DO NOT TOLERATE THE TENSION¿, THAT THEY HAVE BEEN USING THESE SUTURES FOR MORE THAN 20 YEARS AND NEVER HAD PROBLEMS. THEY INFORMED THE TEMPERATURE AT WHICH THEY KEEP THE SUTURES IS ALWAYS LESS THAN 24 ° C. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1912185 ETHLN BLK 18IN 6-0 S/A SC-16 SUTURE, NONABSORBABLE, SYNTHETIC GAR ETHICON INC. AP2999

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown