BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHREX AR-300,HANDPIECE

    MDR report key: 19441503 · Received May 31, 2024

    Report

    Report Number
    1220246-2024-04612
    Event Type
    Malfunction
    Date Received
    May 31, 2024
    Date of Event
    March 21, 2023
    Report Date
    May 31, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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 (B)(6)2023.  ARTHREX HAS REASSESSED THE REPORTABILITY DECISIONS MADE ON HISTORICAL COMPLAINT RECORDS USING REVISED CRITERION. THIS 3500A DOCUMENT IS A RESULT OF THE REASSESSMENT. SEE THE ATTACHED VENDOR EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED ON (B)(6)2023 BY A ARTHREX EMPLOYEE VIA SEMS THAT AN AR-300WD16 WIRE DRIVER ATTACHMENT, AR-300 HANDPIECE, AR-300DJ JACOBS CHUCK, AND AR-300PD24 PIN DRIVER ATTACHMENT ARE OVERHEATING DURING USE. NO CASE INVOLVEMENT, NO PATIENT EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1229601 ARTHREX AR-300,HANDPIECE POWERED SURG ORTHOPEDIC INSTR HWE ARTHREX, INC. ARTHREX AR-300,HANDPIECE 14955787

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown