BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 6085368 · Received November 8, 2016

    Report

    Report Number
    6085368
    Event Type
    Injury
    Date Received
    November 8, 2016
    Date of Event
    October 17, 2016
    Report Date
    October 27, 2016
    Manufacturer
    N/A
    Product Code
    HTW
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING REPAIR OF LEFT LEG QUADRICEPS TENDON RUPTURE, THE DRILL BIT TIP FRACTURED IN THE PATELLA. RETAINED DRILL BIT TIP IN PATELLA CONFIRMED ON XRAYS. THE BENEFIT OUTWEIGHED THE RISK AND THE SURGEON CHOSE TO LEAVE THE DRILL BIT TIP IN THE PATELLA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735736 UNKNOWN BIT, DRILL HTW N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR