BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STLESS STEEL UC SIL 30IN 5 S/A TR-55

    MDR report key: 18414396 · Received December 28, 2023

    Report

    Report Number
    2210968-2023-10275
    Event Type
    Malfunction
    Date Received
    December 28, 2023
    Date of Event
    January 1, 2023
    Report Date
    January 22, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAQ
    PMA / PMN Number
    K946173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: - WAS THERE ANY ADVERSE CONSEQUENCE ASSOCIATED WITH THE PATIENT? NO .- PLEASE PROVIDE THE LOT NUMBER: LOT:THBDEC; LOT: TGBDUK. - IS THE PRODUCT AVAILABLE FOR RETURN? IF SO, WAS IT ALREADY REQUESTED TO MRW? PROVIDE TRACKING NUMBER. THERE WERE THREE BOXES, ONE WAS USED IN THE OPERATING ROOM, I CAN ONLY RETURN TWO BOXES. I HAVE REQUESTED IT FROM MRW BUT THEY HAVE NOT YET SENT ME THE BOX. 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. WHICH PRODUCT CODE BROKE DURING THIS ONE PROCEDURE? WHICH LOT NUMBER BROKE DURING THIS ONE PROCEDURE? HOW MANY SUTURES OF LOT # THBDEC BROKE DURING THIS ONE PROCEDURE? HOW MANY SUTURES OF LOT # TGBDUK BROKE DURING THIS ONE PROCEDURE? WHAT IS BEING RETURNED FOR EVALUATION? PLEASE RETURN ACTUAL OR REPRESENTATIVE SAMPLES OF THE PRODUCT CODE THAT BROKE (W945). HOW MANY EACHES ARE BEING RETURNED? ADDITIONAL INFORMATION: D4 ¿ THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE BATCH NUMBERS: THBDEC, TGBDUK. RELATED MEDWATCH REPORTS: 2210968-2023-10275.

    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. INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO ETHICON FOR EVALUATION. VISUAL INSPECTION AND FUNCTIONAL TESTING WERE CONDUCTED ON THE RETURNED DEVICE. THE RETURNED SAMPLE DETERMINED THAT IT WAS RECEIVED, TWO SEALED BOXES WITH TWELVE UNOPENED SAMPLES EACH THAT PERTAIN TO THE PRODUCT CODE W945, LOT THBDEC. 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, THE 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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: WHICH PRODUCT CODE BROKE DURING THIS ONE PROCEDURE? W945. WHICH LOT NUMBER BROKE DURING THIS ONE PROCEDURE? LOT:THBDEC; LOT: TGBDUK. HOW MANY SUTURES OF LOT # THBDEC BROKE DURING THIS ONE PROCEDURE? SEVERAL. HOW MANY SUTURES OF LOT # TGBDUK BROKE DURING THIS ONE PROCEDURE? SEVERAL. WHAT IS BEING RETURNED FOR EVALUATION? YES. PLEASE RETURN ACTUAL OR REPRESENTATIVE SAMPLES OF THE PRODUCT CODE THAT BROKE (W945). HOW MANY EACHES ARE BEING RETURNED? 2 BOXES (24 EAS). RELATED MEDWATCH REPORTS: 2210968-2023-10276, 2210968-2023-10277, 2210968-2024-00582.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE DOES NOT HAVE ENOUGH TENSILE STRENGTH TO CLOSE THE STERNUM. IT BROKE WHEN THEY WERE GOING TO SEW. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1490378 STLESS STEEL UC SIL 30IN 5 S/A TR-55 SUTURE, NONABSORBABLE, STEEL GAQ ETHICON INC. THBDEC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown