BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMELOCK REVERSED SHOULDER

    MDR report key: 19315591 · Received May 14, 2024

    Report

    Report Number
    3014128390-2024-00028
    Event Type
    Malfunction
    Date Received
    May 14, 2024
    Date of Event
    May 10, 2024
    Report Date
    May 14, 2024
    Manufacturer
    FX SHOULDER SOLUTIONS DALLAS
    Product Code
    LXH
    UDI-DI
    03701037306185
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONTAMINANT MATTER WAS DISCOVERED INSIDE THE CANNULAS 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

    WHEN CHECKING THE INSTRUMENTATION INTO THE HOSPITAL FOR A CASE ON (B)(6) 2024, THE STERILIZATION OFFICER PULLED TWO T HANDLES FROM THE KIT FOR CONTAMINATION. THE STERILIZATION OFFICER BELIEVED THE CONTAMINANT TO BE BLOOD OR BIOBURDEN. BASED ON A REVIEW OF PROVIDED PHOTOS, THE CONTAMINANT IS LIKELY RUST. REGARDLESS, THE PARTS WERE CLEANED TO THE HOSPITAL'S STANDARDS BEFORE CHECK IN WAS FINALIZED. NO SURGICAL DELAY OCCURRED AS THE CASE THE INSTRUMENTATION WAS FOR HAD ALREADY BEEN RESCHEDULED FOR UNRELATED REASONS. CAPA-2024-0027 HAS BEEN OPENED TO ADDRESS THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547606 HUMELOCK REVERSED SHOULDER INSTRUMENT LXH FX SHOULDER SOLUTIONS DALLAS K916 03701037306185

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown PART: 903-0102 LOT: UNK