BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.5MM DRILL

    MDR report key: 8775608 · Received July 10, 2019

    Report

    Report Number
    8775608
    Event Type
    Malfunction
    Date Received
    July 10, 2019
    Date of Event
    May 14, 2019
    Report Date
    June 12, 2019
    Manufacturer
    MIAMI DEVICE SOLUTIONS LLC
    Product Code
    HWC
    UDI-DI
    10812269020487
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SCRUB TECH NOTED THE TIP OF THE DRILL BIT WAS BROKEN AFTER USE IN RIGHT SHOULDER. TIP OF DRILL BIT WAS VISUALIZED ON C-ARM IMAGING. DOCTOR REMOVED BOTH BROKEN PIECES FROM FIELD. IMAGING WAS TAKEN AND SURGEON CONFIRMED NO FOREIGN BODY REMAINED IN PATIENT'S WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572164 2.5MM DRILL SCREW, FIXATION, BONE HWC MIAMI DEVICE SOLUTIONS LLC MDS111125150 BDLY1TS 10812269020487

    Patients

    Seq Age Sex Outcome Treatment
    1 29200 DA