BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW POSITIONING KNOB

    MDR report key: 16427674 · Received February 23, 2023

    Report

    Report Number
    1220246-2023-06337
    Event Type
    Malfunction
    Date Received
    February 23, 2023
    Date of Event
    February 3, 2023
    Report Date
    March 13, 2023
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867362697
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT IS CONFIRMED. ONE UNPACKAGED AR-8741G-02 SCREW POSITIONING KNOB SERIAL/BATCH NUMBER 052111 WAS RECEIVED FOR INVESTIGATION. FUNCTIONAL TESTING WITH THE RETURNED MATTING PART AR-8741G FOUND THE POSITIONING KNOB SCREW ARE NOT SCREWING INTO THE MAIN BRACKET. VISUAL EVALUATION FOUND THAT THE SCREWS THREAD WAS DAMAGED, BEFORE RECEIVED FOR INVESTIGATION. SCREW KNURLED KNOB WITH CRACKS. THE ROOT CAUSE OF THE REPORTED FAILURE MODE IS UNDETERMINED. HOWEVER, THE MOST LIKELY PROBABLE CAUSE IS APPLYING EXCESSIVE MECHANICAL FORCES UPON INSERTION/USE.

    Description of Event or Problem · 0

    IT WAS REPORTED ON 02/03/2023 BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8741G-02 POSITIONING KNOB WOULD NOT SCREW INTO THE AR-8741G DRILL GUIDE. "THE SCREW POSITIONING KNOB FOR THE BUNIONECTOMY MINIMALLY INVASIVE BUNION GUIDE WAS NOT ABLE TO BE SCREWED IN FULLY IN THE CORRECT LOCATION - SCREW IS EITHER DEFECTIVE OR THE C RING GUIDE IS DEFECTIVE. IT CAUSED THE CASE TO GO AN HOUR LONGER THAN USUAL." CASE INVOLVEMENT, DEVIATION FROM PROCEDURE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577658 SCREW POSITIONING KNOB ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. SCREW POSITIONING KNOB 052111 00888867362697

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other