BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIBERTAPE CERCLAGE TENSIONER, REUSABLE

    MDR report key: 18826385 · Received March 4, 2024

    Report

    Report Number
    1220246-2024-01259
    Event Type
    Malfunction
    Date Received
    March 4, 2024
    Date of Event
    February 9, 2024
    Report Date
    August 16, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867273986
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H3, H6. COMPLAINT ALLEGATION IS CONFIRMED. ONE UNPACKAGED (B)(6) SERIAL/BATCH NUMBER 052144 WAS RECEIVED FOR INVESTIGATION. FUNCTIONAL TESTING WAS PERFORMED AND FOUND THAT THE DEVICE DOES HAVE A BURR INSIDE THE SUTURE SLOT THAT CUTS THE SUTURE DURING USE. VISUAL INSPECTION NOTED NO PROBLEMS WITH THE DEVICE. THE MOST LIKELY CAUSE IS ATTRIBUTED TO WEAR AND TEAR DUE TO REPEATED USE OF THE DEVICE.

    Description of Event or Problem · 0

    ON 02/09/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-7800 CERCLAGE TENSIONER IS FRAYING THE SUTURE. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. THE SURGEON HAD TO REDO THE 2 CERCLAGE CABLES ALREADY USED TO FACILITATE PASSING. ADDITIONAL 15 MIN. CASE WAS COMPLETED IN A STANDARD FASHION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167947 FIBERTAPE CERCLAGE TENSIONER, REUSABLE MANUAL INSTR, GENERAL SURGICAL LXH ARTHREX, INC. FIBERTAPE CERCLAGE TENSIONER, REUSABLE 052144 00888867273986

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown