BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUPORT

    MDR report key: 7036826 · Received November 16, 2017

    Report

    Report Number
    3008812173-2017-00026
    Event Type
    Injury
    Date Received
    November 16, 2017
    Date of Event
    October 17, 2017
    Report Date
    February 16, 2018
    Manufacturer
    ZIMMER KNEE CREATIONS, INC.
    Product Code
    FGY
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SURGEON COMMUNICATED THEY INADVERTENTLY BROKE THE CANNULA AFTER LEAVING THE CANNULA IN THE KNEE WHILE MANIPULATE THE KNEE DURING ARTHROSCOPIC SURGERY. PER THE INSTRUCTIONS FOR USE, ¿USE PROPER TECHNIQUE TO REMOVE CANNULA FROM BONE TO AVOID DAMAGED OR BROKEN CANNULA. FULLY INSERT STYLUS INTO CANNULA, THEN REMOVE STYLUS AND CANNULA WITH SURGICAL DRILL IN REVERSE.¿ ADDITIONALLY, UPON REMOVAL OF THE FRAGMENT OF THE DEVICE, BONE FRAGMENTS AND TISSUE DEBRIS WERE CREATED AND THEN CONTAINED IN THE JOINT CAPSULE. THE DRAINAGE IS MOST LIKELY DUE TO THE DEBRIS FROM THE REAMING; THERE WERE NO SIGNS OF INFECTION IN THE SURROUNDING TISSUE WHERE THE DRAINAGE WAS OCCURRING.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION. THIS INVESTIGATION IS ONGOING. A SUPPLEMENT MDR WILL BE SUBMITTED AS NEW INFORMATION IS RECEIVED

    Description of Event or Problem · 1

    BROKEN TIP OF 11 GA CANNULA IN PATIENT.

    Description of Event or Problem · 1

    BROKEN TIP OF 11 GA CANNULA IN PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817989 ACCUPORT 11GA. CANNULA FGY ZIMMER KNEE CREATIONS, INC. N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1