BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPR FT SCRW, 5.0 LG, 50MM LGTH

    MDR report key: 20642248 · Received November 8, 2024

    Report

    Report Number
    1220246-2024-08491
    Event Type
    Injury
    Date Received
    November 8, 2024
    Date of Event
    October 2, 2024
    Report Date
    August 21, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRS
    UDI-DI
    00888867262966
    PMA / PMN Number
    K201132
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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. 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 10/16/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8750-03 DRIVER SHAFT, T15 HEXALOBE, CANNULATED HAD THE TIP OF THE SCREW BREAK OFF IN THE HEAD OF THE SCREW WHEN THE SURGEON WAS TRYING TO BACK OUT THE SCREW. THE CASE WAS COMPLETED SUCCESSFULLY, WITH NO PIECES BREAKING OFF INSIDE THE PATIENT. THIS WAS DISCOVERED DURING A HARDWARE REMOVAL PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 11/04/2024: THERE WAS NO CASE DELAY. THE HARDWARE REMOVAL PROCEDURE WAS FOR THE REMOVAL OF THE ARTHREX PART AR-8750-50H 5.0 LARGE COMPRESSION FT SCREW, WHICH WAS EXPLANTED DURING THE SURGERY. AT THIS TIME, IT IS UNKNOWN WHY THE PATIENT UNDERWENT REVISION SURGERY. NO ARTHREX PRODUCTS WERE IMPLANTED DURING THIS SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1943816 COMPR FT SCRW, 5.0 LG, 50MM LGTH BONE FIXATION PLATE HRS ARTHREX, INC. COMPR FT SCRW, 5.0 LG, 50MM LGTH UNK 00888867262966

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other