BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TROCAR HANDLE

    MDR report key: 5938123 · Received September 8, 2016

    Report

    Report Number
    0001032347-2016-00500
    Event Type
    Injury
    Date Received
    September 8, 2016
    Date of Event
    August 11, 2016
    Report Date
    August 12, 2016
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    KTE
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE PRODUCT CODE IS KTE (NOT AVAILABLE ON DROP DOWN LIST). WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT.

    Additional Manufacturer Narrative · 1

    ALL THREE PARTS (TROCAR HANDLE, CHEEK RETRACTOR, AND DRILL GUIDE) WERE RETURNED ASSEMBLED TOGETHER. THE CHEEK RETRACTOR WAS CLAMPED INTO THE TROCAR HANDLE AND THE DRILL GUIDE WAS INSERTED INTO THE TROCAR HANDLE. THERE APPEARS TO BE NO DAMAGE ON THE TROCAR HANDLE AFTER A VISUAL INSPECTION. ALL THREE PARTS WERE EASILY DISASSEMBLED. A VISUAL INSPECTION OF THE CHEEK RETRACTOR SHOWS THAT THERE ARE SCRATCHES AND SOME MATERIAL DEFORMATION WHERE THE RETRACTOR INTERFACES WITH THE TROCAR HANDLE. THE DRILL GUIDE HAS SOME SCRATCHES ON THE SURFACE THAT IS PRESSED UP AGAINST THE TROCAR HANDLE. WHERE THE DRILL IS INSERTED INTO THE DRILL GUIDE, THERE IS WEAR IN A CIRCULAR PATTERN THAT APPEARS TO BE FROM THE ROTATION HANDLE THAT THE DRILL IS ATTACHED TO. THE THREE PARTS WERE ASSEMBLED AND DISASSEMBLED MULTIPLE TIMES TO TRY TO REPLICATE THE COMPLAINT. EACH TIME THE PARTS WERE EASILY ASSEMBLED AND DISASSEMBLED; THEREFORE THE COMPLAINT IS NOT CONFIRMED. THE MOST LIKELY UNDERLYING CAUSE OF THIS COMPLAINT CANNOT BE DETERMINED AS THE PARTS FUNCTIONED AS INTENDED. THE INSPECTION HISTORY WAS REVIEWED AND NO NON-CONFORMANCES WERE IDENTIFIED. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS.

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE DEVICE EVALUATION. (B)(4).

    Description of Event or Problem · 1

    THE SALES ASSOCIATE REPORTED THERE WAS A PROBLEM WITH THE TROCAR. A PERCUTANEOUS INCISION WAS MADE; THE TROCAR AND CHEEK RETRACTOR WERE PLACED IN THE PATIENT, THE DRILL SLEEVE WAS PLACED INTO THE HAND PIECE/CHEEK RETRACTOR AND BECAME LODGED. APPROXIMATELY 30 MINUTES LATER, IT WAS REALIZED THAT THE DRILL GUIDE (SLEEVE) HAD DROPPED INTO THE CHEEK RETRACTOR AND THE TROCAR HANDLE, AND BY USING COVERS, FORCEPS, THEY WERE ABLE TO DISASSEMBLE AND USE A KOHKER TO REMOVE THE INITIAL INSTRUMENT. THE AVAILABLE SECOND TRAUMA ONE SET WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589915 TROCAR HANDLE HANDLE KTE BIOMET MICROFIXATION N/A 329695

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention