BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AOQC DRILL BIT

    MDR report key: 6900228 · Received September 28, 2017

    Report

    Report Number
    3008951116-2017-00008
    Event Type
    Malfunction
    Date Received
    September 28, 2017
    Date of Event
    August 2, 2017
    Report Date
    August 18, 2017
    Manufacturer
    ORTHO SOLUTIONS UK LTD
    Product Code
    JDR
    PMA / PMN Number
    K111678
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE 2.5MM SINGLE USE DRILL BIT BROKE IN PATIENT FEMUR DURING HIP REPLACEMENT SURGERY. SURGEON TRIED UNSUCCESSFULLY TO RETRIEVE THE BROKEN PIECE. BROKEN DRILL RETAINED FOR INSPECTION AND THE EVENT REPORTED TO (B)(4). AN X-RAY WAS TAKEN TO DISCUSS WITH PATIENT POST SURGERY. INVESTIGATION CURRENTLY UNDERWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680045 AOQC DRILL BIT DRILL JDR ORTHO SOLUTIONS UK LTD N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1