BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILLING GUIDE DEPTH GAUGE

    MDR report key: 21963607 · Received May 5, 2025

    Report

    Report Number
    3014128390-2025-00019
    Event Type
    Malfunction
    Date Received
    May 5, 2025
    Date of Event
    April 17, 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. THERE WERE 20 MINUTES OF SURGICAL DELAY AS THE SURGICAL TEAM USED ANOTHER SET OF INSTRUMENTATION TO CONTINUE THE SURGERY. THE INSTRUMENT SET IN QUESTION HAS BEEN IDENTIFIED. IT WAS SHIPPED TO THE DISTRIBUTOR 14-APR-2025, AND RETURNED TO FX SHOULDER SOLUTIONS ON 23-APR-2025. THE CASE PERFORMED ON 17-APR-2025 WAS THE ONLY CASE PERFORMED BY THE DISTRIBUTOR. 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
    423860 DRILLING GUIDE DEPTH GAUGE ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH FX SHOULDER SOLUTIONS DALLAS T0505 03701037316894

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown