BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAR SLEEVE, VELCRO

    MDR report key: 19420175 · Received May 29, 2024

    Report

    Report Number
    1220246-2024-04290
    Event Type
    Malfunction
    Date Received
    May 29, 2024
    Date of Event
    March 1, 2022
    Report Date
    May 29, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    KQZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. "PER CUSTOMER DEVICE WILL NOT BE RETURNED, DEVICE WAS DISCARDED." THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO A MANUFACTURING ISSUE; HOWEVER, DUE TO THE DEVICE NOT BEING RETURNED, WE ARE UNABLE TO CONFIRM THE REPORTED EVENT.

    Description of Event or Problem · 0

    ON 03/01/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-1606V SLEEVE HAD HAIR IN THE PACKAGING. THIS WAS DISCOVERED DURING AN UNKNOWN CASE, WITH NO PATIENT EFFECT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593757 STAR SLEEVE, VELCRO NONINVASIVE TRACTION COMPONENT KQZ ARTHREX, INC. STAR SLEEVE, VELCRO 54270357

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown