BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIBERTAPE CERCLAGE TENSIONER, REUSABLE

    MDR report key: 22903991 · Received August 27, 2025

    Report

    Report Number
    1220246-2025-03668
    Event Type
    Malfunction
    Date Received
    August 27, 2025
    Date of Event
    August 12, 2025
    Report Date
    December 17, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867273986
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX WAS ABLE TO CONCLUDE A MOST LIKELY CAUSE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR OF THE DEVICE DUE TO EXCESSIVE FORCE USED DURING SUTURE PASSING/TIGHTENING /TENSIONING. REF: FIBERTAPE® CERCLAGE SYSTEM LB1-000073-EN-US. 1. PAY ATTENTION TO THE NUMBERS ON THE TENSIONER. DON¿T TENSION BEYOND THE 80 MARK TO AVOID ¿BLOWING OUT¿ THE KNOT. THERE IS NO RECOMMENDED NUMBER TO TENSION TO. SURGEONS SHOULD RELY ON TACTILE FEEL, AS THEY WOULD WITH CABLE AND WIRE CERCLAGE

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    ON 08/12/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-7800 FIBERTAPE CERCLAGE TENSIONER CLAVICLE TENSIONER WAS CUTTING THE SUTURES WHEN RELEASING. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1250683 FIBERTAPE CERCLAGE TENSIONER, REUSABLE MANUAL INSTR, GENERAL SURGICAL LXH ARTHREX, INC. FIBERTAPE CERCLAGE TENSIONER, REUSABLE 052126 00888867273986

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown