BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VA LOCKING SCREW, 1.4X8MM

    MDR report key: 19668442 · Received July 3, 2024

    Report

    Report Number
    1220246-2024-06573
    Event Type
    Malfunction
    Date Received
    July 3, 2024
    Date of Event
    June 6, 2024
    Report Date
    June 13, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRS
    UDI-DI
    00888867303720
    PMA / PMN Number
    K191326
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    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 IMPROPER BONE PREPARATION AND/OR PRYING/LEVERAGING THE SCREW DURING INSERTION.

    Description of Event or Problem · 0

    ON 06/06/2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT AN AR-18700-09 DRIVER SHAFT AND AN AR-18700-29 DRIVER SHAFTS TIPS BROKE OFF. THIS OCCURRED DURING A CASE WHERE THE DRIVERS BROKE OFF INTO THE AR-18714V-08 SCREW HEAD IN THE AR-18714P-12 PLATE. ONE OF THE TIPS FROM AN AR-18700-29 DRIVER COULD NOT BE RETRIEVED AS IT COLD WELDED TO THE SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473678 VA LOCKING SCREW, 1.4X8MM BONE FIXATION PLATE HRS ARTHREX, INC. VA LOCKING SCREW, 1.4X8MM UNK 00888867303720

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown