BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOW PROFILE SCREW, 1.4X7MM, CORTICAL, TI

    MDR report key: 17099758 · Received June 9, 2023

    Report

    Report Number
    1220246-2023-06886
    Event Type
    Malfunction
    Date Received
    June 9, 2023
    Date of Event
    May 11, 2023
    Report Date
    February 21, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRS
    UDI-DI
    00888867303836
    PMA / PMN Number
    K191326
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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

    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 BROKEN SCREW CAN BE ATTRIBUTED TO MISUSE DUE TO MISALIGNED INSERTION; OR PRYING/LEVERAGING THE SCREW DURING INSERTION.

    Description of Event or Problem · 0

    ON (B)(6)2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT (2) AR-18714-07 LOW PROFILE SCREW BREAK DURING INSERTION INTO THE PLATE. THIS WAS DISCOVERED DURING A METACARPAL FX PROCEDURE ON (B)(6)2023. THE SCREWS REMAIN INSIDE THE PATIENT. ADDITIONAL INFORMATION REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2151328 LOW PROFILE SCREW, 1.4X7MM, CORTICAL, TI BONE FIXATION PLATE HRS ARTHREX, INC. LOW PROFILE SCREW, 1.4X7MM, CORTICAL, TI 1095585 00888867303836

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other