BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHREX AR-600,HANDPIECE

    MDR report key: 19431933 · Received May 30, 2024

    Report

    Report Number
    1220246-2024-04482
    Event Type
    Malfunction
    Date Received
    May 30, 2024
    Date of Event
    October 25, 2022
    Report Date
    May 30, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 MOST LIKELY CAUSE OF THE REPORTED FAILURE IS WEAR AND TEAR. SEE ATTACHED FOR SUPPLIER EVALUATION.

    Description of Event or Problem · 0

    ON 10/25/2022, IT WAS REPORTED BY A ARTHREX EMPLOYEE VIA SEMS THAT A AR-600 HANDPIECE IS OVERHEATING. THIS OCCURRED DURING AN UNSPECIFIED TIME, WITH NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1215111 ARTHREX AR-600,HANDPIECE POWERED SURG ORTHOPEDIC INSTR HWE ARTHREX, INC. ARTHREX AR-600,HANDPIECE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown