BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CPLT F&A KIT 3CC 11G END

    MDR report key: 8021127 · Received October 30, 2018

    Report

    Report Number
    3008812173-2018-00037
    Event Type
    Malfunction
    Date Received
    October 30, 2018
    Date of Event
    October 1, 2018
    Report Date
    December 12, 2018
    Manufacturer
    ZIMMER KNEE CREATIONS, INC.
    Product Code
    OJH
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER DRILLING THE CANNULA INTO THE TALUS WITHOUT TOGGLE, THE SURGEON CONFIRMED BY TOUCHING THE CANNULA THAT IT WAS NOT HOT. HOWEVER, THE ACCUFILL FAILED TO FLOW THROUGH THE CANNULA. THIS RESULTED IN A DELAY OF ABOUT 30-45 MINUTES. THERE WAS NO REPORTED IMPACT TO THE PATIENT AS A RESULT OF THE DELAY. THE DEVICE WAS NOT RETURNED, AS IT WAS DISCARDED AT THE HOSPITAL. DURING THE INVESTIGATION, IT WAS NOTED THAT THE PATIENT HAD PARTICULARLY HARD BONE, WHICH MAY HAVE ATTRIBUTED TO THE HEATING OF THE CANNULA. AFTER SECOND KIT WAS USED, THE ACCUFILL WAS ABLE TO FLOW APPROPRIATELY, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE INVESTIGATION ENGINEER REVIEWED THE CASE AND SURGICAL TECHNIQUE WITH THE SALES REPRESENTATIVE TO COOL THE ACCUPORT WITH 2CC OF SALINE PER THE SURGICAL TECHNIQUE GUIDE IF HEAT IS GENERATED WHILE DRILLING INTO THE BONE.

    Description of Event or Problem · 0

    ACCUFILL WOULD NOT FLOW THROUGH CANNULA.

    Additional Manufacturer Narrative · 1

    AFTER DRILLING THE CANNULA INTO THE TALUS WITHOUT TOGGLE, THE SURGEON CONFIRMED BY TOUCHING THE CANNULA THAT IT WAS NOT HOT. HOWEVER, THE ACCUFILL FAILED TO FLOW THROUGH THE CANNULA. THIS RESULTED IN A DELAY OF ABOUT 30-45 MINUTES. THERE WAS NO REPORTED IMPACT TO THE PATIENT AS A RESULT OF THE DELAY. THE DEVICE WAS NOT RETURNED, AS IT WAS DISCARDED AT THE HOSPITAL. A SECOND KIT WAS USED, THE ACCUFILL WAS ABLE TO FLOW APPROPRIATELY, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. ONCE ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ACCUFILL WOULD NOT FLOW THROUGH CANNULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862462 CPLT F&A KIT 3CC 11G END SCP KIT OJH ZIMMER KNEE CREATIONS, INC. N/A KC05325

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR