BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NANOGRIP, NANOSCOPE OPTICS HANDLE

    MDR report key: 19568488 · Received June 19, 2024

    Report

    Report Number
    1220246-2024-06165
    Event Type
    Malfunction
    Date Received
    June 19, 2024
    Date of Event
    May 27, 2021
    Report Date
    June 19, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    NBH
    UDI-DI
    00888867362208
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    501

    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 COMPLAINT DEVICE WAS NOT RECEIVED FOR EVALUATION. BASED OFF THE INFORMATION PROVIDED, THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR IN FITTING THE DEVICE CORRECTLY TO THE MATING PART. WITHOUT THE RETURN OF THE DEVICE FOR PHYSICAL EVALUATION, THE COMPLAINT ALLEGATION CANNOT BE CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A WRIST PROCEDURE, THE AR-1090NH-1 WAS OPENED FOR THE CASE BUT THE CASE SCOPE DID NOT WORK AND THE AR-1090NH-1 COULD NOT BE USED. THE CASE WAS COMPLETED BY USING A DIFFERENT WRIST SCOPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625600 NANOGRIP, NANOSCOPE OPTICS HANDLE ARTHROSCOPIC ACCESSORIES NBH ARTHREX, INC. NANOGRIP, NANOSCOPE OPTICS HANDLE 12534173 00888867362208

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown