BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOLOC® DRILL BIT 1/8

    MDR report key: 9397504 · Received December 2, 2019

    Report

    Report Number
    3010536692-2019-01155
    Event Type
    Malfunction
    Date Received
    December 2, 2019
    Date of Event
    October 24, 2019
    Report Date
    January 31, 2020
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    GFG
    UDI-DI
    M684161090081
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE ALLEGED COMPLAINT IS CONFIRMED. THIS COMPLAINT WAS REPORTED BY A MICROPORT DISTRIBUTOR. THE DEVICE HISTORY RECORDS WERE REVIEWED FOR ALL PRODUCTS LISTED AND THE PRODUCTS MET SPECIFICATION AT THE TIME THEY WERE MANUFACTURED. THIS FAILURE MODE IS LISTED IN THE DEVICE PACKAGE INSERT AND RISK DOCUMENTATION. THE INSTRUMENT CLEANING AND HANDLING INSTRUCTIONS (150802-2) INDICATE THAT THE INSTRUMENTS ARE SUSCEPTIBLE TO DAMAGE OVER TIME AND SHOULD BE INSPECTED PRIOR TO AND AFTER EACH USE. IN ADDITION, THE CLEANING AND HANDLING INSTRUCTIONS ALSO STATE, "END OF FUNCTIONAL LIFE IS NORMALLY DETERMINED BY WEAR AND DAMAGE DUE TO USE." PER THE INCIDENT DESCRIPTION, THE PRODUCT WAS NOT RETURNED. NO IMAGES WERE PROVIDED FOR EVALUATION. THERE WERE NO TRENDS IDENTIFIED. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH COMPLAINT TRACKING.

    Description of Event or Problem · 0

    ALLEGEDLY , TIP OF 1/8 ADVANCE DRILL BIT BROKE OFF IN PATIENT WHILE DRILLING TIBIAL SCREW HOLES. APPROX 10MM REMAINED IN-SITU. INSTEAD OF A SCREW BEING IMPLANTED INTO THE FOURTH HOLE ON THE BIOFOAM, THE BROKEN PIECE OF THE DRILL BIT REMAINS IN PLACE. 3 SCREWS ONLY WERE IMPLANTED.

    Additional Manufacturer Narrative · 1

    THIS EVENT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    ALLEGEDLY , TIP OF 1/8 ADVANCE DRILL BIT BROKE OFF IN PATIENT WHILE DRILLING TIBIAL SCREW HOLES. APPROX 10MM REMAINED IN-SITU. INSTEAD OF A SCREW BEING IMPLANTED INTO THE FOURTH HOLE ON THE BIOFOAM, THE BROKEN PIECE OF THE DRILL BIT REMAINS IN PLACE. 3 SCREWS ONLY WERE IMPLANTED. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1193897 ORTHOLOC® DRILL BIT 1/8 KNEE INSTRUMENT GFG MICROPORT ORTHOPEDICS INC. 16109008 606411 M684161090081

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention