BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIO-TRANSFIX, 5MM X 40MM

    MDR report key: 1380608 · Received May 11, 2009

    Report

    Report Number
    1220246-2009-00074
    Event Type
    Other
    Date Received
    May 11, 2009
    Date of Event
    April 15, 2009
    Report Date
    April 17, 2009
    Manufacturer
    ARTHREX, INC.
    Product Code
    MNU
    PMA / PMN Number
    K011172
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REQUESTED FOR EVAL, BUT WAS NOT RETURNED BECAUSE IT HAD BEEN DISCARDED BY THE FACILITY; THEREFORE, THE COMPLAINANT'S EVENT COULD NOT BE VERIFIED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFO AVAILABLE AND WITHOUT DEVICE EVAL. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. BASED ON THE INFO PROVIDED, THE MOST LIKELY CAUSE OF THIS TYPE OF EVENT IS IMPROPER BONE PREPARATION, INSERTING THE IMPLANT AT AN ANGLE THAT IS NOT PERPENDICULAR TO THE PILOT HOLE, PRYING/LEVERAGING THE DRIVER WHILE THE IMPLANT IS STILL LOADED, OR APPLYING EXCESSIVE FORCE TO THE SCREW DURING IMPLANTATION. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HEAD OF THE IMPLANT BROKE OFF DURING AN ACL REPAIR, BUT THE SHAFT REMAINED IN THE PT. AS THE IMPLANT WAS BEING SEATED INTO THE BONE, THE THREADED END BEGAN TO CRACK AND BREAK OFF. ALL LOOSE PIECES THAT BROKE OFF WERE RETRIEVED, BUT THE BODY OF THE IMPLANT REMAINED UN-RETRIEVED FROM THE BONE DUE TO GOOD FIXATION OF THE GRAFT. THE SURGERY WAS REPORTED AS COMPLETED SUCCESSFULLY WITH THE IMPLANT AS IS; NO ADD'L IMPLANTS WERE USED. NO FURTHER PT INFO WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO F/U COMMUNICATION. NO ADD'L 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 BIO-TRANSFIX, 5MM X 40MM MNU ARTHREX, INC. NA 176158

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Other INFO REQUESTED BUT NOT PROVIDED.