BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACL REPAIR TIGHTROPE, WITH INTERNALBRACE

    MDR report key: 19562862 · Received June 18, 2024

    Report

    Report Number
    1220246-2024-06013
    Event Type
    Injury
    Date Received
    June 18, 2024
    Date of Event
    May 1, 2024
    Report Date
    September 13, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    MBI
    UDI-DI
    00888867363656
    PMA / PMN Number
    K231857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    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 A PATIENT-SPECIFIC EVENT.

    Description of Event or Problem · 0

    ON 01 MAY 2024 IT WAS REPORTED BY A PRODUCT SURVEILLANCE SPECIALIST IN ARTHREX INC THAT THEY HAD RECEIVED A REPORT OF A POTENTIAL ADVERSE EVENT THAT OCCURRED DURING A CLINICAL STUDY IN THE UNIVERSITY OF WESTERN AUSTRALIA. THE ARTHREX PRODUCTS THAT WERE INVOLVED WERE: AR-1588R-IB ACL REPAIR TIGHTROPE, WITH INTERNALBRACE, AR-2324PSLC-1 PEEK SWIVELOCK C,4.75X19.1MM & AR-7282-25-1 FIBERRING WITH SHUTTLE SUTURE25MM,SINGLE. IT WAS REPORTED THAT THE PATIENT EXPERIENCED POST-OPERATIVE PARTIAL OCCLUSION OF PERONEAL VEIN, TREATED WITH ELIQUIS WITH FULL RECOVERY AND WITHOUT FURTHER SEQUALAE. MORE INFORMATION TO BE CONFIRMED. THERE WAS CASE INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1185100 ACL REPAIR TIGHTROPE, WITH INTERNALBRACE NON-DEGRADABLE FIXATN FASTENER MBI ARTHREX, INC. ACL REPAIR TIGHTROPE, WITH INTERNALBRACE UNK 00888867363656

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention