BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T15 HEXALOBE, ISO, CANN.

    MDR report key: 11990939 · Received June 14, 2021

    Report

    Report Number
    1220246-2021-03267
    Event Type
    Malfunction
    Date Received
    June 14, 2021
    Date of Event
    May 27, 2021
    Report Date
    June 14, 2021
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867263765
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FULKERSON OSTEOTOMY, WHEN THE SURGEON WAS PLACING THE SCREWS, THE TIPS OF THE AR-8750-03 TWISTED OFF ON WERE STUCK ONTO THE SCREW, THIS ISSUE OCCURRED TWICE DURING THE PROCEDURE. BOTH FRAGMENTS WERE REMOVED FROM THE PATIENT. NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    893446 T15 HEXALOBE, ISO, CANN. ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ARTHREX, INC. T15 HEXALOBE, ISO, CANN. 031833 00888867263765

    Patients

    Seq Age Sex Outcome Treatment
    1