BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    #2 FW W/TPR NDL 36.6MM 1/2 CIRCLE

    MDR report key: 17053362 · Received June 2, 2023

    Report

    Report Number
    1220246-2023-06830
    Event Type
    Malfunction
    Date Received
    June 2, 2023
    Date of Event
    May 9, 2023
    Report Date
    October 16, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    GAT
    UDI-DI
    00888867041349
    PMA / PMN Number
    K122374
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    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 USER ERROR OF THE DEVICE DUE TO EXCESSIVE FORCE USED DURING SUTURE PASSING.

    Description of Event or Problem · 0

    ON 05/09/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-7206 FIBERWIRE NEEDLE IS BREAKING. THIS WAS DISCOVERED DURING A CASE, DEVICE BREAKS DURING USE. PER FACILITY: "USES THE WIRE WHEN CLOSING CAPSULE AFTER TOTAL HIP, AND THE NEEDLE KEEPS BREAKING. DR. FREEMAN HAS BEEN EXPERIENCING THIS ISSUE WITH MULTIPLE OF THE FIBER WIRE NEEDLES IN VARIOUS CASES. NO HARM TO PATIENT, BROKEN NEEDLES ARE DISCARDED, AND NEW ONES ARE USED TO FINISH THE CASE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1370480 #2 FW W/TPR NDL 36.6MM 1/2 CIRCLE POLYETHYLENE SYNTHETIC SUTURE GAT ARTHREX, INC. #2 FW W/TPR NDL 36.6MM 1/2 CIRCLE UNK 00888867041349

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown