BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VICRYL RAP UND 75CM M2 USP3/0 SGLE ARMED PS-2 PRIME

    MDR report key: 23584836 · Received November 18, 2025

    Report

    Report Number
    2210968-2025-12935
    Event Type
    Malfunction
    Date Received
    November 18, 2025
    Date of Event
    October 14, 2025
    Report Date
    November 18, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K033746
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    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. 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: DID THE REPORTED ISSUE CONTRIBUTE TO ANY PATIENT ADVERSE CONSEQUENCES? NO WAS THE NEEDLE PIECE(S) RETRIEVED DURING THE SAME PROCEDURE? YES, SAME PROCEDURE WERE X-RAYS TAKEN TO LOCATE THE NEEDLE PIECE(S)? NO X-RAY WAS NEEDED AS NEEDLE RECOVERED MANUALLY. WHAT MEASURES WERE IMPLEMENTED TO RETRIEVE THE BROKEN PIECE? MANUAL ¿ IT WAS A CLEAN BREAK. WAS THERE ANY ADDITIONAL TISSUE DAMAGE RESULTING FROM THE SEARCH FOR THE NEEDLE PIECE? NO TISSUE DAMAGE WAS NOTED. COULD YOU PLEASE PROVIDE THE LOT NUMBER? THE HCP DIDN¿T HAVE THE LOT NUMBER, ONLY THE EXPIRY DATE AND CODE. THE CUSTOMER ANSWERING THE QUESTIONS WAS (B)(6), TEAM LEADER FOR ENT, (B)(6). THE MANUFACTURING RECORDS COULD NOT BE REVIEWED AS THE BATCH/LOT NUMBER IS UNKNOWN. D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE.

    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, WHEN CLOSING THE WOUND, THE STITCH USED BROKE RIGHT AT THE TIP (3-0 VYCRIL RAPID REF W9923, EXP 2030-01). THE SURGEON NOTICE THE BREAKAGE AND WAS ABLE TO RETRIEVE THE BROKEN PIECE. COMPARED WITH OTHER NEEDLE AND NOTHING WAS MISSING; IT WAS A CLEAN BREAK. ALTHOUGH THE SURGEON DID ADMIT TOUCHING THE BONE WITH THE NEEDLE WHICH MIGHT BE THE REASON FOR IT TO BREAK, NOT VERY USUAL FOR THIS TO HAPPEN. DEVICE IS NOT AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1989332 VICRYL RAP UND 75CM M2 USP3/0 SGLE ARMED PS-2 PRIME SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown