BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, CANN DELTA TAPERED BIO-INT, 9MM

    MDR report key: 2061776 · Received April 19, 2011

    Report

    Report Number
    1220246-2011-00058
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    March 24, 2011
    Report Date
    March 24, 2011
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    PMA / PMN Number
    K062466
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHICS (AGE AT TIME OF EVENT, DATE OF BIRTH, WEIGHT) WERE REQUESTED, BUT NOT PROVIDED. NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO FOLLOW-UP COMMUNICATION. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT. THE DEVICE WAS REQUESTED FOR EVALUATION BUT WAS NOT RETURNED, THEREFORE, THE COMPLAINANT'S EVENT COULD NOT BE VERIFIED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. DEVICE HISTORY RECORD REVEALED NOTHING RELEVANT TO THIS EVENT. COMPLAINANT'S EVENT TYPICALLY CAUSED BY PRYING AND LEVERAGING THE IMPLANT, ANGULATING THE DRIVER OR FLEXING THE JOINT DURING INSERTION. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. THE POTENTIAL CAUSES OF THIS EVENT ARE BEING COMMUNICATED TO THE EVENT REPORTER. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. DISCARDED BY FACILITY.

    Description of Event or Problem · 1

    DURING ACL SOFT TISSUE PROCEDURE, IMPLANT WOULD NOT SEAT AS THREADS WERE STRIPPED. THIS WAS REMOVED. SECOND ATTEMPT TO INSERT ANOTHER OF THE SAME TYPE OF SCREW BUT IT BROKE ON INSERTION AT THE TIP. TIP REMAINS IN PATIENT. A SECOND INSERTION POINT WAS DRILLED ADJACENT AND REPLACED WITH A COMPETITOR IMPLANT AND CASE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREW, CANN DELTA TAPERED BIO-INT, 9MM FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE MAI ARTHREX, INC. 307538

    Patients

    Seq Age Sex Outcome Treatment
    1 Other AR-5035TB-09 LOT 253752