BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCRYL UD 18IN 3-0 S/A PS-2 PRM MP

    MDR report key: 19791756 · Received July 22, 2024

    Report

    Report Number
    2210968-2024-07445
    Event Type
    Malfunction
    Date Received
    July 22, 2024
    Date of Event
    June 24, 2024
    Report Date
    November 5, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    UDI-DI
    10705031059399
    PMA / PMN Number
    K964072
    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. H6 COMPONENT CODE: G07002 DEVICE NOT RETURNED. 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. 1. ANY PATIENT CONSEQUENCES? 2. WERE THERE ANY UNEXPECTED OUTCOMES OR COMPLICATIONS AS A RESULT OF THE PROLONGED SURGERY TIME? 3. WAS THERE ANY CHANGE IN THE PATIENT¿S POST-OPERATIVE CARE DUE TO THE PROLONGED PROCEDURE? A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 8/28/2024. H6 COMPONENT CODE: G07002 NO DEVICE PROBLEM FOUND. ADDITIONAL INFORMATION: D9, H3, H6. H3 INVESTIGATIONAL SUMMARY: THE PRODUCT WAS RETURNED TO ETHICON FOR EVALUATION. TWO SEALED BOXES WITH TWELVE UNOPENED SAMPLES EACH WERE RECEIVED FOR ANALYSIS THAT BELONG TO PRODUCT CODE Y497G. AS PER THE SAMPLING PLAN, A VISUAL INSPECTION WAS PERFORMED ON THIRTEEN SAMPLES, AND NO DEFECTS WERE FOUND ON THE PACKAGES. THE PACKETS WERE OPENED, AND THE SWAGE AND ATTACHMENT AREA WERE NOTED AS EXPECTED. THE SUTURES WERE DISPENSED WITHOUT PROBLEMS AND EXAMINED ALONG OF THE STRAND AND NO ISSUES RELATED TO BREAKAGE SUTURES OR ANOMALIES WERE OBSERVED DURING THE EVALUATION. ALSO, A FUNCTIONAL TEST WAS PERFORMED USING INSTRON EQUIPMENT AND TENSILE FORCE WAS ABOVE THE MINIMUM REQUIREMENTS. 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. 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.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 11/5/2024. ADDITIONAL INFORMATION WAS REQUESTED, THE FOLLOWING WAS OBTAINED: 1. ANY PATIENT CONSEQUENCES? NO. 2. WERE THERE ANY UNEXPECTED OUTCOMES OR COMPLICATIONS AS A RESULT OF THE PROLONGED SURGERY TIME? NO. 3. WAS THERE ANY CHANGE IN THE PATIENT¿S POST-OPERATIVE CARE DUE TO THE PROLONGED PROCEDURE? NO. 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 HIP REPLACEMENT ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, AFTER CLOSING THE WOUND ON THE HIP AREA, THE SUTURE BROKE BEFORE THE KNOT COULD BE TIED. ANOTHER LIKE DEVICE WAS USED TO CLOSE THE WOUND. THE SURGERY WAS DELAYED 10 MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1165275 MCRYL UD 18IN 3-0 S/A PS-2 PRM MP SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC. UAMDDC 10705031059399

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown