BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TROCAR HANDLE

    MDR report key: 6556981 · Received May 10, 2017

    Report

    Report Number
    0001032347-2017-00387
    Event Type
    Malfunction
    Date Received
    May 10, 2017
    Date of Event
    April 13, 2017
    Report Date
    May 10, 2017
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    KTE
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. THE LOT NUMBER IS UNKNOWN; THEREFORE THE DEVICE HISTORY RECORDS ARE UNABLE TO BE REVIEWED. 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. DEVICE PRODUCT CODE: KTE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE TROCAR HANDLE HAS A LEVER THAT IS STUCK. THE LEVER THAT SWITCHES THE TROCAR FROM DRILL TO SCREW WAS LODGED AND EVEN AFTER SOAKING IN MILK WAS STILL UNABLE TO SWITCH THE LEVER. THERE WAS NO SURGERY OR PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338847 TROCAR HANDLE EAR, NOSE, AND THROAT MANUAL SURGICAL INSTRUMENT KTE BIOMET MICROFIXATION N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1