BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRO

    MDR report key: 11541485 · Received March 22, 2021

    Report

    Report Number
    11541485
    Event Type
    Malfunction
    Date Received
    March 22, 2021
    Date of Event
    February 4, 2021
    Report Date
    March 16, 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

    THE PATIENT WAS A TRAUMA CASE WITH MULTIPLE INJURIES. DURING A REPAIR OF A FRACTURED PELVIS, 2 OF THE 2.5MM DRILL BITS, FROM THE STRYKER PRO SYSTEM, FRACTURED OFF DURING SCREW APPLICATION. TIPS OF THE DRILL BITS WERE LEFT IN THE BONE. THE OTHER PART OF THE BIT IS AVAILABLE FOR MANUFACTURER INSPECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442024 PRO ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER TRAUMA SA 703966

    Patients

    Seq Age Sex Outcome Treatment
    1 9490 DA