BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SFXSYM PDS+ UNI VIO 24IN 1 SA CT

    MDR report key: 24643506 · Received March 19, 2026

    Report

    Report Number
    2210968-2026-02829
    Event Type
    Malfunction
    Date Received
    March 19, 2026
    Date of Event
    February 9, 2026
    Report Date
    March 19, 2026
    Manufacturer
    ETHICON, INC.
    Product Code
    NEW
    UDI-DI
    10705031245235
    PMA / PMN Number
    K141776
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # ==>(B)(4). H3 PHOTO INVESTIGATION 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 NEEDLE HELD WITH A SURGICAL NEEDLE; IT APPEARS PARTIALLY BROKEN SEVERAL TOOLING MARKS WERE OBSERVED TROUGH THE NEEDLE BODY. AS WITH ANY DEVICE, CARE MUST BE TAKEN TO AVOID DAMAGING THE NEEDLE WHEN HANDLING IT. AVOID CRUSHING OR CRIMPING ACTION OF SURGICAL INSTRUMENTS SUCH AS NEEDLE HOLDERS AND FORCEPS. AS PART OF ETHICON QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL H11: SFXSYM PDS+ UNI VIO 24IN 1 SA CT - SXPP1A444 (LOT: 1096LC) (SXPP1A444): NOT APPLICABLE SFXSYM PDS+ UNI VIO 24IN 1 SA CT - SXPP1A444 (LOT: 1096LC) (SXPP1A444): LOT/BATCH NUMBER: 1096LC LIST ANY J&J PRODUCTS THAT WERE UTILIZED DURING THE CASE BUT DID NOT CONTRIBUTE TO THE REPORTED EVENT. ## *** WAS THERE ANY REPORTED PATIENT OR USER HARM? ## NO *** WAS THERE A SIGNIFICANT DELAY? ## YES *** HOW LONG WAS THE DELAY (MINUTES)? ## 10-15 *** IF AVAILABLE, PROVIDE THE PRODUCT ORDER NUMBER (PO). ## (B)(4). 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, AND THE FOLLOWING WAS OBTAINED VIA: 1. FOR THE MOMENT, NO COMPLICATIONS. IN THE END , THEY STOPPED USING STRATAFIX AND STARTED USING ANOTHER SUTURE. 2. FOR THE MOMENT, NO CHANGE IN THE PATIENT¿S POST-OPERATIVE CARE. IN THE END , THEY STOPPED USING STRATAFIX AND STARTED USING ANOTHER SUTURE. 3. CONTACT PERSON: NURSE (B)(6) TEL: (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, DURING PROCEDURE, USING A STRATAFIX, THE NEEDLE BENT FROM THE MIDDLE ACCORDING TO PICTURE. THEY TRIED TO USE ANOTHER ONE, SAME LOT WITH THE SAME OUTCOME. PATIENT CONSEQUENCES: NONE. THE PROCEDURE WAS DELAYED WITH 10-15 MINUTES. LOT : 1096LC, CODE: SXPP1A444. DURING THE VISUAL ANALYSIS, THE FOLLOWING WAS OBSERVED: THE PHOTO SHOWS A NEEDLE HELD WITH A SURGICAL NEEDLE; IT APPEARS PARTIALLY BROKEN SEVERAL TOOLING MARKS WERE OBSERVED TROUGH THE NEEDLE BODY. AS WITH ANY DEVICE, CARE MUST BE TAKEN TO AVOID DAMAGING THE NEEDLE WHEN HANDLING IT. AVOID CRUSHING OR CRIMPING ACTION OF SURGICAL INSTRUMENTS SUCH AS NEEDLE HOLDERS AND FORCEPS. AS PART OF ETHICON QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703307 SFXSYM PDS+ UNI VIO 24IN 1 SA CT SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE NEW ETHICON, INC. 1096LC 10705031245235

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown