BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILLING GUIDE DEPTH GAUGE

    MDR report key: 21963608 · Received May 5, 2025

    Report

    Report Number
    3014128390-2025-00020
    Event Type
    Malfunction
    Date Received
    May 5, 2025
    Date of Event
    April 23, 2025
    Report Date
    May 5, 2025
    Manufacturer
    FX SHOULDER SOLUTIONS DALLAS
    Product Code
    LXH
    UDI-DI
    03701037316894
    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-2025-0030 HAS BEEN OPENED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 0

    DURING A CASE WITH THE SURGEON ON (B)(6) 2025, THE DRILL GUIDE WAS DISCOVERED TO HAVE BONE DEBRIS OBSTRUCTING THE CANNULA. THE INSTRUMENT WAS FLUSHED WITH BETADINE WASH IN THE SURGICAL SUITE, AS THE SURGEON FELT THE DEBRIS WAS AT LEAST STERILE. THERE WAS NO SURGICAL DELAY. A PHOTO RETURNED DOES CONFIRM THE ISSUE. THE INSTRUMENT SET IN QUESTION HAS BEEN IDENTIFIED. IT WAS SHIPPED TO THE DISTRIBUTOR, AND IS NOT YET RETURNED TO FX SHOULDER SOLUTIONS. THE CASE PERFORMED ON 23-APR-2025 BY THE DISTRIBUTOR WAS THE FIRST CASE PERFORMED DURING THIS TIME. THE INSTRUMENT IN QUESTION WAS NOT ADEQUATELY INSPECTED OR CLEANED BY FX SHOULDER SOLUTIONS WAREHOUSE STAFF. CAPA-2025-0030 HAS BEEN OPENED TO ADDRESS THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423861 DRILLING GUIDE DEPTH GAUGE ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH FX SHOULDER SOLUTIONS DALLAS T2063 03701037316894

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown