BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRO

    MDR report key: 11964787 · Received June 9, 2021

    Report

    Report Number
    11964787
    Event Type
    Malfunction
    Date Received
    June 9, 2021
    Date of Event
    May 21, 2021
    Report Date
    June 1, 2021
    Manufacturer
    STRYKER TRAUMA SA
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS HAVING AN OPEN REDUCTION WITH INTERNAL FIXATION OF THE PELVIS. 6-HOLE 3.5 MM RECONSTRUCTION PLATE WAS APPLIED ALONG THE INNER PELVIC BRIM WITH SCREWS PLACED PROXIMALLY IN AN ANTI-GLIDE COMPRESSIVE FASHION, AND THE LAG SCREWS THROUGH THE ANTERIOR COLUMN INTO THE POSTERIOR COLUMN. STABLE FIXATION OBTAINED. DURING THIS PROCESS A STRYKER TRAUMA SA SCALED 2.5 DRILL BIT BROKE OFF. THE BROKEN PIECE WAS LEFT IN THE BONE. INSTRUMENTS ARE BROUGHT IN A TRAY BY THE STRYKER FIELD REPRESENTATIVE, SO HEALTH CARE PROVIDERS DON'T HAVE THE ORIGINAL PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860763 PRO ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER TRAUMA SA 703966

    Patients

    Seq Age Sex Outcome Treatment
    1 18980 DA