BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK

    MDR report key: 19470213 · Received June 5, 2024

    Report

    Report Number
    1220246-2024-04964
    Event Type
    Malfunction
    Date Received
    June 5, 2024
    Date of Event
    April 27, 2022
    Report Date
    June 5, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 COMPLAINT IS CONFIRMED BASED ON THE CUSTOMER-PROVIDED X-RAYS, WHICH DISPLAY THE BACKED OUT SCREWS. HOWEVER, AS THE DEVICES WERE NOT RETURNED FOR PHYSICAL EVALUATION, THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO A PATIENT-SPECIFIC EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED ON 04/27/2022 BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN UNIDENTIFIED SET OF SCREWS HAD APPARENTLY BEGUN TO BACK OUT OF THE PATIENTS FOOT. PER FACILITY: "I AM REACHING OUT BECAUSE ONE OF MY SURGEONS REACHED OUT AND NOTICED THAT THE NEW MIS BEVELED SCREWS BACKED OUT SLIGHTLY IN HIS PATIENTS A COUPLE WEEKS POST OP. PLEASE SEE ATTACHED PICS THAT HE SENT ME FROM HIS PATIENTS¿ FOLLOW UP VISITS. IN BOTH INSTANCES, THE SCREWS WERE FLUSH AND MAYBE SLIGHTLY COUNTERSINK IN THE PATIENTS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    806498 UNK UNK LXH ARTHREX, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown