BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 21985579 · Received May 8, 2025

    Report

    Report Number
    2210968-2025-05051
    Event Type
    Malfunction
    Date Received
    May 8, 2025
    Date of Event
    April 9, 2025
    Report Date
    May 8, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAQ
    PMA / PMN Number
    K946173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT: (B)(4). H6 COMPONENT CODE: G07002 - DEVICE NOT RETURNED 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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL PATIENT EVENTS. ATTEMPTS WERE MADE TO OBTAIN THE INFORMATION. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. PLEASE PROVIDE AN ANSWER FOR EACH CASE: (B)(4) CAPTURES THE INITIAL REPORT FOR "PRODUCT CODE W945...AS PER THE USERS IT IS NOT SUITABLE TO THE SURGICAL PROCEDURES BECAUSE IT BREAKS." - (B)(4) CAPTURES THE AMBIGUOUS MULTIPLE EVENT REPORT. - PLEASE CONFIRM THE NUMBER OF PATIENTS AFFECTED BY THIS ALLEGED DEFICIENCY. - HAVE ANY OF THESE EVENTS BEEN PREVIOUSLY REPORTED TO ETHICON? IF SO, PROVIDE THE RESPECTIVE REFERENCE NUMBER(S). * IF NOT, PLEASE CREATE A NEW PC FILE FOR EACH PATIENT/EVENT. - WHEN DID THE SUTURE BREAKAGE OCCURRED (REMOVAL FROM PACKAGE / DURING HANDLING PRIOR TO USE ON PATIENT/ DURING PASSAGE THROUGH TISSUE / DURING TYING / POST-OP)? - PLEASE CONFIRM BELOW, HOW MANY DEVICES DEMONSTRATED THE REPORTED ALLEGED DEFICIENCY OF EACH LOT? * LOT THBEUM: * LOT TJBAXB: * LOT TCBAPX: * LOT TGBDUK: - PLEASE CONFIRM BELOW, HOW MANY DEVICES ARE AVAILABLE FOR PRODUCT ANALYSIS OF EACH LOT? * LOT THBEUM: * LOT TJBAXB: * LOT TCBAPX: * LOT TGBDUK: - WERE THERE PATIENT CONSEQUENCES? IF YES, PLEASE EXPLAIN. - PLEASE PERFORM AND DOCUMENT THE FOLLOW UP ATTEMPT FOR PRODUCT RETURN. PLEASE DOCUMENT THE SHIPMENT TRACKING NUMBER IN NOTES OR RMAO SECTIONS. - PROVIDE THE SOURCE OR NAME AND TITLE OF EXTERNAL PERSON PROVIDING ANSWERS TO FOLLOW-UP (EXTERNAL PERSON SUBMITTING ANSWERS TO SALES REP OR LOC/BQ). D4: FULL UDI CURRENTLY UNAVAILABLE SINCE THE EXACT LOT OF THE SUSPECTED DEVICE CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). CORRECTED INFORMATION: B1, H1 - THIS MEDWATCH REPORT IS BEING VOIDED AS IT DOES NOT MEET THE CRITERIA OF A REPORTABLE EVENT UNDER US FDA REGULATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, PRODUCT CODE W945 USED AS ALTERNATIVE TO ANOTHER ONE (UNKNOWN) AND AS PER THE USERS IT IS NOT SUITABLE TO THE SURGICAL PROCEDURES BECAUSE IT BREAKS. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760952 STLESS STEEL UC SIL 30IN 5 S/A TR-55 SUTURE, NONABSORBABLE, STEEL GAQ ETHICON INC. TGBDUK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown