BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUPORT SIDE TARGETED CANNULA (SELF-DRILLING)

    MDR report key: 2975230 · Received January 24, 2013

    Report

    Report Number
    3008812173-2013-00001
    Event Type
    Malfunction
    Date Received
    January 24, 2013
    Report Date
    January 3, 2013
    Manufacturer
    KNEE CREATIONS LLC
    Product Code
    FGY
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING TESTING IN HOUSE, THE PRODUCT FAILURE WAS ABLE TO BE REPLICATED. FROM FURTHER ANALYSIS AND INVESTIGATION, IT WAS DETERMINED THAT THE PRODUCT FAILURE WAS A RESULT OF FAILURE TO FOLLOW MANUFACTURER INSTRUCTIONS BY THE USER.

    Description of Event or Problem · 1

    DURING A BONE VOID FILLING PROCEDURE OF A FEMORAL CONDYLE OF THE RIGHT KNEE THE SURGEON USED ACCUPORT SIDE TARGETED (SELF-DRILLING) CANNULA, PART (B)(4). HE PERFORMED THE PROCEDURE BY FREE HAND- MEANING HE CHOSE NOT TO USE THE NAVIGATION TARGETING GUIDE INSTRUMENTS THAT WERE PROVIDED WITH THE CANNULA FOR THE PROCEDURE. DURING INITIAL TARGETING AND INSERTION OF THE CANNULA, THE SURGEON BELIEVED HE DID NOT ADEQUATELY TARGET THE BONE VOID SO HE REMOVED THE CANNULA PARTIALLY FROM THE INITIAL SITE AND DIRECTED THE CANNULA TO A NEW LOCATION IN THE BONE. AFTER THE INTRODUCTION OF BONE SUBSTITUTE MATERIAL TO THE SITE, THE SURGEON LEFT THE CANNULA INSIDE THE BONE AND STATED HE WAS UNABLE TO REINSERT THE INNER CANNULA STYLUS. THE SURGEON THEN PROCEEDED WITH AN ARTHROSCOPY AND ACL RECONSTRUCTION ON THE SAME KNEE WITH THE CANNULA STILL INSIDE THE BONE. THE KNEE WAS FLEXED, EXTENDED, AND MANIPULATED DURING THIS PART OF THE PROCEDURE. FOLLOWING THE SECOND PART OF THE PROCEDURE, THE SURGEON PROCEEDED TO REMOVE THE CANNULA. AS HE REMOVED THE CANNULA, APPROXIMATELY 10 TO 15MM OF THE TIP REMAINED INSIDE THE FEMORAL CONDYLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35100 ACCUPORT SIDE TARGETED CANNULA (SELF-DRILLING) NONE FGY KNEE CREATIONS LLC 307.032 25878

    Patients

    Seq Age Sex Outcome Treatment
    1