BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 11759662 · Received May 3, 2021

    Report

    Report Number
    11759662
    Event Type
    Malfunction
    Date Received
    May 3, 2021
    Date of Event
    March 21, 2021
    Report Date
    April 26, 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

    SURGEON WAS USING A STRYKER 1806-4260S ORTHOPEDIC 4.2 X 340MM AO NON-STERILE DRILL BIT DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE DISTAL FEMUR WHEN THE TIP OF THE DRILL BIT BROKE OFF IN THE DISTAL FEMUR OF THE PATIENT. THE SURGEON STATED THAT IT WOULD CAUSE MORE DAMAGE TO TRY TO REMOVE THE TIP THAN TO LEAVE IT IN THE FEMUR. 5.5 CM IS THE LENGTH OF THE TIP OF THE DRILL BIT THAT BROKE OFF AND REMAINED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659422 NA ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER TRAUMA SA 1806-4260S K08C906

    Patients

    Seq Age Sex Outcome Treatment
    1