BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVER SHAFT, T8, SELF RETAINING, AO

    MDR report key: 19457252 · Received June 4, 2024

    Report

    Report Number
    1220246-2024-04806
    Event Type
    Malfunction
    Date Received
    June 4, 2024
    Date of Event
    April 12, 2023
    Report Date
    June 4, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867316270
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS 3500A RECORD IS SUBMITTED TO COMPLY WITH AN FDA 483 INSPECTIONAL OBSERVATION ISSUED TO ARTHREX INC ON MAY 5, 2023. ARTHREX HAS REASSESSED THE REPORTABILITY DECISIONS MADE ON HISTORICAL COMPLAINT RECORDS USING REVISED CRITERION. THIS 3500A DOCUMENT IS A RESULT OF THE REASSESSMENT. THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED/RECEIVED FOR EVALUATION. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE IS USE ERROR DUE TO PRYING/LEVERAGING AND/OR MISALIGNED INSERTION.

    Description of Event or Problem · 0

    ON 04/12/2023 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-18700-54 DRIVER SHAFT WOULD NOT MATE. THIS WAS DISCOVERED DURING AN UNSPECIFIED TIME WITH NO PATIENT EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653685 DRIVER SHAFT, T8, SELF RETAINING, AO ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. DRIVER SHAFT, T8, SELF RETAINING, AO 1392223 00888867316270

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown