BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NABS SUR SUT USP PROLENE* NW834

    MDR report key: 23715839 · Received December 4, 2025

    Report

    Report Number
    2210968-2025-13598
    Event Type
    Malfunction
    Date Received
    December 4, 2025
    Date of Event
    January 7, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4) DATE SENT TO THE FDA: 12/4/2025. 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, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, 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 INFORMATION WAS REQUESTED, THE FOLLOWING WAS OBTAINED: DID THE NEEDLE FALL INTO THE PATIENT? IF YES, WAS THE NEEDLE PIECE(S) RETRIEVED DURING THE SAME PROCEDURE? WERE X-RAYS TAKEN TO LOCATE THE NEEDLE PIECE(S)? WHAT MEASURES WERE TAKEN TO RETRIEVE THE BROKEN PIECE? WAS THERE ANY ADDITIONAL TISSUE DAMAGE AS A RESULT OF SEARCHING FOR THE NEEDLE PIECE? COULD YOU KINDLY PROVIDE THE LOT NUMBER, PLEASE? COULD YOU KINDLY PERFORM AND DOCUMENT THE FOLLOW-UP ATTEMPT FOR THE PRODUCT RETURN? FURTHERMORE, PLEASE ENSURE THAT THE SHIPMENT TRACKING NUMBER IS RECORDED IN THE NOTES OR RMAO SECTIONS. PLEASE PROVIDE THE SOURCE OR NAME OF PERSON PROVIDING ANSWERS TO FOLLOW-UP QUESTIONS: THE NEEDLE FALL ON THE PATIENT THE NEEDLE WAS RETRIEVED DURING THE SAME PROCEDURE NO X-RAYS WERE TAKEN TO LOCATE THE NEEDLE PIECES BROKEN PIECE WAS RETRIEVED WITH NEEDLE HOLDER NO ADDITIONAL TISSUE DAMAGE BATCH NUMBER UNKNOWN-HAVE TO CHECK HOSPITAL RECORDS AND BILLS PRODUCT IN CUSTODY OF ME DR. (B)(6) AND OR NURSE (B)(6) IS GIVING INFORMATION FOR THE QUESTIONS. 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. D4/G4: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THEREFORE, (01)GTIN IS NOT AVAILABLE. THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, A MANUFACTURING RECORD EVALUATION COULD NOT BE PERFORMED.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 1/14/2026. 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, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, 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: C22 - PHOTO ANALYSIS. ADDITIONAL INFORMATION: H6. H3 INVESTIGATIONAL SUMMARY: THIS IS AN ANALYSIS FOR A PHOTO SUBMITTED TO ETHICON FOR EVALUATION. DURING THE VISUAL ANALYSIS, THE FOLLOWING WAS OBSERVED: THE PHOTO SHOWS A CONTAINER WITH AN APPARENTLY BROKEN NEEDLE IN THE TIP SECTION. CLEAR ANALYSIS OF THE NEEDLE COULD NOT BE PERFORMED DUE TO ITS POSITION. BASED ON THE PHOTO REVIEW, THE EVENT REPORTED 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 DEVICE WAS NOT RETURNED OUR EVALUATION IS LIMITED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. NW834 SUTURE NEEDLE BROKE IN BETWEEN SUTURING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218069 NABS SUR SUT USP PROLENE* NW834 SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown