BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROX LATERAL TIBIA PLATE, LFT, 5 HOLE

    MDR report key: 19369393 · Received May 22, 2024

    Report

    Report Number
    1220246-2024-03623
    Event Type
    Malfunction
    Date Received
    May 22, 2024
    Date of Event
    August 31, 2022
    Report Date
    May 22, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRS
    UDI-DI
    00848665032239
    PMA / PMN Number
    K202489
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. DEVICE IS NOT EXPECTED TO RETURN. THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO MISUSE/MISHANDLING DUE TO DAMAGE TO THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED ON 08/31/2022 BY A SALES REPRESENTATIVE VIA EMAIL THAT A 3081-105 TIBIAL PLATE WOULD NOT LOCK INTO THE 3.56 VAL SCREWS, THE CASE WAS COMPLETED USING THE 4.0 LOCKING SCREWS. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1788641 PROX LATERAL TIBIA PLATE, LFT, 5 HOLE BONE FIXATION PLATE HRS ARTHREX, INC. PROX LATERAL TIBIA PLATE, LFT, 5 HOLE 220404 00848665032239

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown