BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FW,BPB #2 SUTR,BLU W/NDL

    MDR report key: 16303002 · Received February 6, 2023

    Report

    Report Number
    1220246-2023-06215
    Event Type
    Injury
    Date Received
    February 6, 2023
    Date of Event
    December 9, 2022
    Report Date
    June 12, 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

    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

    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.

    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.

    Description of Event or Problem · 0

    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
    114669 FW,BPB #2 SUTR,BLU W/NDL SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ARTHREX, INC. FW,BPB #2 SUTR,BLU W/NDL 24738 00888867041264

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other