BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T10 HEXALOBE, CMP FT

    MDR report key: 11911909 · Received June 1, 2021

    Report

    Report Number
    1220246-2021-03174
    Event Type
    Malfunction
    Date Received
    June 1, 2021
    Date of Event
    May 12, 2021
    Report Date
    June 1, 2021
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867127166
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 THE TIP OF THE AR-8737-38 DRIVER BROKE-OFF WHILE INSERTING SCREW INSIDE OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    813974 T10 HEXALOBE, CMP FT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ARTHREX, INC. T10 HEXALOBE, CMP FT 1392008 00888867127166

    Patients

    Seq Age Sex Outcome Treatment
    1