BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOW PROFILE SCREW, 1.6 X 9MM, CORTICAL

    MDR report key: 14674434 · Received June 13, 2022

    Report

    Report Number
    1220246-2022-05057
    Event Type
    Malfunction
    Date Received
    June 13, 2022
    Date of Event
    May 24, 2022
    Report Date
    October 13, 2022
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRS
    UDI-DI
    00888867313217
    PMA / PMN Number
    K191326
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT IS NOT CONFIRMED BASED ON THE CUSTOMER PROVIDED PHOTO, WHICH DISPLAYS THE PLATE AND SCREWS. IT CANNOT BE DETERMINED BASED ON THE PHOTO IF THE HEADS OF THE SCREWS ARE PRESENT. HOWEVER, WITHOUT RETURN OF THE DEVICE FOR PHYSICAL EVALUATION, THE CAUSE REMAINS UNDETERMINED. NO CHANGE IN HARM WAS IDENTIFIED.

    Description of Event or Problem · 0

    ON 5/25/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-18716-09 CORTICAL SCREW HEAD BROKE OFF WHILE BEING INSERTED INTO THE AR-18714P-10 PLATE. THE HEAD WAS REMOVED FROM INSIDE THE PATIENT, HOWEVER, THE BODY OF THE SCREW REMAINS IMPLANTED. THIS WAS DISCOVERED DURING A 2ND METACARPAL BASE FRACTURE PROCEDURE ON (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    846487 LOW PROFILE SCREW, 1.6 X 9MM, CORTICAL PLATE, FIXATION, BONE HRS ARTHREX, INC. LOW PROFILE SCREW, 1.6 X 9MM, CORTICAL UNK 00888867313217

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown