BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SFX SPI PDS+ BI VIO 14IN2 USP1 D/A CTX

    MDR report key: 24895886 · Received April 16, 2026

    Report

    Report Number
    2210968-2026-04049
    Event Type
    Malfunction
    Date Received
    April 16, 2026
    Date of Event
    January 1, 2026
    Report Date
    April 16, 2026
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    UDI-DI
    10705031464544
    PMA / PMN Number
    K192144
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 4/16/2026 H6 COMPONENT CODE: G07002 - PENDING EVALUATION OF RETURNED DEVICE THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803, PART 4 SUBPART B. 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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. ADDITIONAL INFORMATION WAS REQUESTED, THE FOLLOWING WAS OBTAINED: -DID THE REPORTED ISSUE CONTRIBUTE TO ANY PATIENT ADVERSE CONSEQUENCES? THERE WERE NO ADVERSE CONSEQUENCES. - HOW MANY DEVICES DEMONSTRATED THE ALLEGED DEFICIENCY? FOUR INDIVIDUAL SUTURE PACKETS. - DID THE EVENT OCCUR DURING ONE OR MULTIPLE PATIENT PROCEDURES? IT OCCURRED OVER 2 PATIENT PROCEDURES THAT I AM AWARE OF. - COULD YOU KINDLY PERFORM AND DOCUMENT THE FOLLOW-UP ATTEMPT FOR THE PRODUCT RETURN? I WAS SENT A RETURN BOX FOR THE REMAINING SUTURES IN THE LOT, AND SHIPPED THEM AS DIRECTED. - PLEASE PROVIDE THE SOURCE OR NAME OF PERSON PROVIDING ANSWERS TO FOLLOW-UP QUESTIONS: JM A DEVICE HAS BEEN RECEIVED, HOWEVER IT HAS NOT YET BEEN EVALUATED. ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN TOTAL KNEE ARTHROPLASTY PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. IT WAS REPORTED BY THE SALES REP THAT, THE NEEDLES POPPING OFF DURING USAGE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112052 SFX SPI PDS+ BI VIO 14IN2 USP1 D/A CTX SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE NEW ETHICON INC. 109ZQ1 10705031464544

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown