BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FW,BPB #2 SUTR,BLU W/NDL

    MDR report key: 19532577 · Received June 13, 2024

    Report

    Report Number
    1220246-2024-05722
    Event Type
    Injury
    Date Received
    June 13, 2024
    Date of Event
    January 6, 2023
    Report Date
    December 26, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    GAT
    UDI-DI
    00888867041264
    PMA / PMN Number
    K122374
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H3, H6. SINCE THE COMPLAINT DEVICE WAS NOT RETURNED, A PHYSICAL EVALUATION OF THE DEVICE WAS NOT PERFORMED. HOWEVER, WITHOUT THE DEVICE BEING RETURNED, PHOTOS, OR ANY DOCUMENTATION PROVIDED, THE REPORTED EVENT IS NOT CONFIRMED. THE MOST LIKELY CAUSE OF THIS FAILURE IS ATTRIBUTED TO A PATIENT'S INFECTION REACTION.

    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 1/18/2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-1400TB BIO-INTERFERENCE SCREW FULL THREAD, AN AR-1588T ACL TIGHTROPE, (3) AR-2324BCC-2 BIO COMPOSITE SWIVELOCK, (3) AR-4500 MENISCAL CINCH, (4) AR-7200 FIBERWIRE, AND (2) AR-7237 FIBERTAPE WERE ALL IMPLANTED IN THE PATIENT. THIS ACL AND LIGAMENT PROCEDURE TOOK PLACE ON (B)(6) 2023. PATIENT DEVELOPED AN INFECTION POST OPERATIVE AND PATIENT REMAINS ADMITTED TO THE HOSPITAL FOR TREATMENT. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME. ADDITIONAL INFORMATION RECEIVED ON 5/15/2024: THE PATIENT HAS NOT UNDERGONE REVISION SURGERY, AND NO FURTHER INFORMATION HAS BEEN RECEIVED REGARDING THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1123964 FW,BPB #2 SUTR,BLU W/NDL POLYETHYLENE SYNTHETIC SUTURE GAT ARTHREX, INC. FW,BPB #2 SUTR,BLU W/NDL 24720 00888867041264

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other