BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    MDR report key: 19214386 · Received April 30, 2024

    Report

    Report Number
    3014128390-2024-00024
    Event Type
    Malfunction
    Date Received
    April 30, 2024
    Date of Event
    April 11, 2024
    Report Date
    April 30, 2024
    Manufacturer
    FX SHOULDER SOLUTIONS DALLAS
    Product Code
    LXH
    UDI-DI
    03701037312308
    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

    AS INSTRUMENTS WERE UNPACKED BY SPD, TWO INSTRUMENTS WERE SEEN TO BE CONTAMINATED. THE STEM IMPACTOR HAD APPARENT HUMAN BONE FRAGMENTS STUCK INSIDE THE THREADING OF THE CENTRAL COLUMN. ADDITIONALLY, THE DRILL GUIDE SHEATH HAD RUST OR ANOTHER CONTAMINANT INSIDE THE CANNULA. THE RESULT WAS A 2-HOUR SURGICAL DELAY AS THE INSTRUMENTS WERE WASHED TWICE IN SUCCESSION TO MAKE SURE THEY WERE THOROUGHLY CLEANED. CAPA 2024-0027 HAS BEEN OPENED TO ADDRESS THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2134302 ORTHOPEDIC MANUAL SURGICAL INSTRUMENT IMPACTOR LXH FX SHOULDER SOLUTIONS DALLAS UNK 03701037312308

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown PART: 951-0023 LOT: T2480