BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTERNAL SHEATH

    MDR report key: 19247826 · Received May 6, 2024

    Report

    Report Number
    1220246-2024-02802
    Event Type
    Malfunction
    Date Received
    May 6, 2024
    Date of Event
    August 30, 2021
    Report Date
    May 6, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867302044
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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 MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO IMPROPER BONE PREPARATION AND/OR PRYING/LEVERAGING THE DEVICE DURING INSERTION.

    Description of Event or Problem · 0

    ON 8/30/2021 IT WAS REPORTED BY SALES REP VIA EMAIL THAT AR-8973-07 FIBULOCK DRILL GUIDE SLEEVE WILL NOT FIT INTO THE FIBULOCK JIG THE WAY IS SUPPOSED TO, CAUSING RESISTANCE. SURGEON WAS ABLE TO PLATE ANKLE REGARDLESS, SUCCESSFULLY COMPLETING PROCEDURE. NO PATIENT AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613617 EXTERNAL SHEATH ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. EXTERNAL SHEATH 1392016 00888867302044

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown