BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRANSFIX II TUNNEL HOOK, 7 MM FOR AR-1975

    MDR report key: 1371605 · Received February 10, 2009

    Report

    Report Number
    1220246-2009-00004
    Event Type
    Other
    Date Received
    February 10, 2009
    Date of Event
    January 9, 2009
    Report Date
    January 13, 2009
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED AND THE EVALUATION IS CURRENTLY IN PROGRESS. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. THE MOST LIKELY CAUSES OF THIS TYPE OF EVENT ARE TYPICALLY CAUSED BY FLEXION/EXTENSION OF THE JOINT OR LEVERAGING OF THE HOOK WHILE THE HOOK IS STILL IN THE BONE TUNNEL. 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 THE ADDITIONAL RELEVANT INFORMATION IS OBTAINED FROM THE EVALUATION, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE SURGEON WAS PULLING OUT THE TRANSFIX HOOK THAT ATTACHES TO THE GUIDE, THE TOP PORTION OF THE TRANSFIX HOOK BROKE WITHIN THE REMOVAL TUNNEL. THE SURGEON WAS ABLE TO INSERT A SCOPE IN THE KNEE SPACE TO CONFIRM THAT THE BROKEN PORTION OF THE TRANSFIX HOOK WAS LODGED IN THE KNEE SPACE. THE HOOK WAS NOT RETRIEVED. THE SURGERY WAS SUCCESSFULLY COMPLETED. NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THE 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSFIX II TUNNEL HOOK, 7 MM FOR AR-1975 LXH ARTHREX, INC. NA 02012206

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Other INFORMATION REQUESTED BUT NOT PROVIDED