BEUDAMED
    FDA Adverse Event Injury Summary report: N

    K-LESS T-ROPE W/DRV, SYN REPR, TI

    MDR report key: 19941490 · Received August 8, 2024

    Report

    Report Number
    1220246-2024-07108
    Event Type
    Injury
    Date Received
    August 8, 2024
    Date of Event
    May 29, 2024
    Report Date
    July 2, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    HTN
    UDI-DI
    00888867281608
    PMA / PMN Number
    K043248
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H3, H6. BASED ON THE VISUAL 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 DUE TO MISALIGNED INSERTION AND/OR IMPROPER BONE PREPARATION.

    Description of Event or Problem · 0

    UPDATE AVOE 11-SEP-2024. IT WAS CONFIRMED THAT THE WOUND REVISIONS TOOK PLACE FROM THE (B)(6) 2024 AND THE IDENTIFIED PATHOGEN WAS STAPHYLOCOCCUS AUREUS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON THE (B)(6) 2024 THE PATIENT UNDERWENT A SYNDESMOSIS SURGERY WHERE A TIGHTROPE + PLATE WERE IMPLANTED. AFTER THE SURGERY THE PATIENT GOT AN INFECTION, WHICH ACCORDING TO THE SURGEON COULD BE CAUSED BY THE TIGHTROPE. NO FURTHER INFORMATION WAS PROVIDED. ***UPDATE AVOE 23-JUL-2024 FURTHER INFORMATION WAS PROVIDED THAT THE PATIENT GOT A DEEP WOUND INFECTION AND OSTEITIS IN THE LOWER LEFT LEG. THE IDENTIFIED PATHOGEN IS STAPHYLOCOCCUS AUREUS. THE PATIENT IS CURRENTLY TREATED IN HOSPITAL WITH MULTIPLE REVISION OPERATIONS WITH METAL REMOVAL, MULTIPLE IRRIGATIONS AND JET LAVAGE, IV ANTIBIOTICS. THIS IS THE 4TH INFECTION WITH TIGHT ROPE XP IN 2 YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1531170 K-LESS T-ROPE W/DRV, SYN REPR, TI WASHER, BOLT, NUT HTN ARTHREX, INC. K-LESS T-ROPE W/DRV, SYN REPR, TI 15116120 00888867281608

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other