BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOW PROFILE SCREW, 1.4X12MM, CORTICAL,TI

    MDR report key: 21079440 · Received January 6, 2025

    Report

    Report Number
    1220246-2025-09215
    Event Type
    Malfunction
    Date Received
    January 6, 2025
    Date of Event
    December 6, 2024
    Report Date
    August 22, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRS
    UDI-DI
    00888867303829
    PMA / PMN Number
    K191326
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    501

    Narratives

    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 USER ERROR OF THE DEVICE DUE TO EXCESSIVE FORCE BEING USED DURING INSERTION OF THE SCREW AND/OR PRYING/LEVERAGING THE DEVICE DURING INSERTION.

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    ON 12/9/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-18714-12 CORTICAL SCREW BROKE MID-SHAFT. THE SURGEON STATED THAT THE SCREW DISINTEGRATED AND BROKE LIKE PLASTIC. THE SCREW WAS REMOVED, AND THE PATIENT WAS NOT AFFECTED. THE CASE WAS DELAYED TWENTY-FIVE MINUTES AS THE SCREW KEPT FALLING APART MORE AND MORE DURING REMOVAL. THE CASE ENDED SUCCESSFULLY AFTER THE REMOVAL AND INSERTION OF ANOTHER SCREW FROM THE SAME SET. THIS WAS DISCOVERED DURING AN ORIF PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 12/17/2024: PER THE SALES REPRESENTATIVE, X-RAY IMAGES WERE TAKEN; HOWEVER, THEY WERE NOT SAVED. THE CASE WAS DELAYED ABOUT TWENTY MINUTES AND ADDITIONAL ANESTHESIA WAS ADMINISTERED. THERE WERE NO OTHER ISSUES WITH ANY OTHER ARTHREX PRODUCT DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357011 LOW PROFILE SCREW, 1.4X12MM, CORTICAL,TI BONE FIXATION PLATE HRS ARTHREX, INC. LOW PROFILE SCREW, 1.4X12MM, CORTICAL,TI 2755601 00888867303829

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown