BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLENOID RESURFACING REAMER

    MDR report key: 19050955 · Received April 5, 2024

    Report

    Report Number
    3014128390-2024-00019
    Event Type
    Malfunction
    Date Received
    April 5, 2024
    Date of Event
    March 13, 2024
    Report Date
    April 5, 2024
    Manufacturer
    FX SHOULDER SOLUTIONS DALLAS
    Product Code
    LXH
    UDI-DI
    03701037312117
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONTAMINANT MATTER WAS DISCOVERED INSIDE THE CANNULA OF AN INSTRUMENT IN THE FIELD, AS THE PRODUCT WAS NOT SATISFACTORILY INSPECTED AND DECONTAMINATED. CAPA-2024-0027 HAS BEEN OPENED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 0

    INSTRUMENT KIT WAS SHIPPED OUT TO THE DOCTOR FOR A CASE ON (B)(6) 2024. THE INSTRUMENT KIT WAS RECEIVED, CHECKED IN, AND STERILIZED PER HOSPITAL PROTOCOL. UPON PREPARING FOR THE IMMINENT SURGERY, THE KIT WAS OPENED. THE REVERSE GLENOID SHOULDER TRAY WAS TAKEN OUT. IT WAS DISCOVERED THAT TWO OF THE INCLUDED BONE REAMERS HAD BONE MATTER IN THE CANNULAS. THIS WAS NOT CAUGHT BY THE HOSPITAL SPD AS THEY DO NOT INDIVIDUALLY INSPECT ITEMS. SURGEON AND REPRESENTATIVE EXPRESSED DISCONTENT THAT THE BONE MATTER WAS NOT CAUGHT BEFORE SHIPMENT OUT OF FX WAREHOUSE. RESULTED IN AN HOUR OF SURGICAL DELAY. CAPA-2024-0027 IS BEING OPENED TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86958 GLENOID RESURFACING REAMER BONE REAMER LXH FX SHOULDER SOLUTIONS DALLAS N3517 03701037312117

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown PART: 906-0026 LOT: N1739