BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCE(R) DRILL BIT W/QUICK DISCONNECT***

    MDR report key: 3974049 · Received August 1, 2014

    Report

    Report Number
    3010536692-2014-01067
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 3, 2014
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DATABASE WAS REVIEWED AND ANALYSIS SHOWED NO TREND FOR ITEM/LOT.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS NOT COMPLETE. THE TRENDS WILL BE EVALUATED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS EVENT OCCURRED IN THE (B)(6). THIS IS THE SAME EVENT AS 3010536692-2014-01066 AND 01067.

    Description of Event or Problem · 1

    WHEN DRILLING IN THE 75MM K0001015 PIN IT LOCKED IN THE BLOCK, THE TIP BROKE IN THE QUICK RELEASE CHUCK. IT WAS NOT POSSIBLE TO REMOVE THE PIN FROM THE JIG SO IT WAS BROKEN AT BOTH ENDS TO ALLOW IT TO BE PLACED ON THE BONE AND ANOTHER HOLE WAS USED TO FIXATE THE BLOCK. IT IS BEING RETURNED TO HQ WITH THE DRILL STILL IN THE JIG. IT IS UNKNOWN WHY THE PIN JAMMED IN THE HOLE AND THE TIP BROKE. SURGERY TIME WAS EXTENDED GREATER THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451175 ADVANCE(R) DRILL BIT W/QUICK DISCONNECT*** KNEE INSTRUMENT LXH MICROPORT ORTHOPEDICS INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1