BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FDL IMPLANT SYSTEM, 4.75 MM

    MDR report key: 22720614 · Received August 5, 2025

    Report

    Report Number
    1220246-2025-03262
    Event Type
    Malfunction
    Date Received
    August 5, 2025
    Date of Event
    July 10, 2025
    Report Date
    November 6, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    UDI-DI
    00888867315150
    PMA / PMN Number
    K051726
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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. THE COMPLAINT DEVICE WAS NOT RECEIVED FOR EVALUATION. 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 THE MOST LIKELY CAUSE. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE IS USER ERROR, INCLUDING IMPROPER BONE PREPARATION AND INCORRECT SURGICAL TECHNIQUE DURING DEVICE APPLICATION. THESE FACTORS MAY HAVE CONTRIBUTED TO THE MALFUNCTION OR COMPROMISED THE INTEGRITY OF THE IMPLANT DURING THE PROCEDURE. THE COMPLAINT ALLEGATION COULD NOT BE CONFIRMED, AS THE DEVICE WAS NOT RECEIVED FOR EVALUATION, AND NO EVIDENCE OF THE REPORTED FAILURE WAS PROVIDED.

    Description of Event or Problem · 0

    ON 07/16/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT DURING AN FHL TRANSFER PROCEDURE PERFORMED ON (B)(6) 2025, AN AR-1547BC-CP FDL IMPLANT SYSTEM EXPERIENCED A MALFUNCTION. SPECIFICALLY, THE 4.75 MM TENODESIS SCREW BROKE IN HALF AT ITS TOP WHILE BEING INSERTED HALFWAY. ALL BROKEN FRAGMENTS WERE RETRIEVED FROM THE PATIENT. TO COMPLETE THE PROCEDURE, THEY UTILIZED THE 5 MM REAMER INCLUDED IN THE KIT TO REAM OVER THE SITE AND SUCCESSFULLY IMPLANTED A 6.25 MM TENODESIS SCREW WITHOUT FURTHER ISSUES. THE CASE WAS DELAYED BY 15 MINUTES, WITH NO ADDITIONAL ANESTHESIA REQUIRED. NO ADVERSE EFFECTS WERE REPORTED DURING OR AFTER THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2651796 FDL IMPLANT SYSTEM, 4.75 MM BONE FIXATION SCREW/PLATE HWC ARTHREX, INC. FDL IMPLANT SYSTEM, 4.75 MM 15376888 00888867315150

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown