BEUDAMED
    FDA Adverse Event Other Summary report: N

    SCREW, BIO-INTERFERENCE SHEATHED, 10X23MM

    MDR report key: 1202755 · Received October 10, 2008

    Report

    Report Number
    1220246-2008-00208
    Event Type
    Other
    Date Received
    October 10, 2008
    Date of Event
    September 9, 2008
    Report Date
    September 15, 2008
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    PMA / PMN Number
    K062466
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REQUESTED FOR EVAL BUT WAS NOT RETURNED, THEREFORE THE COMPLAINANT'S EVENT COULD NOT BE VERIFIED. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. NOT ENOUGH INFO WAS PROVIDED TO MAKE A DETERMINATION AS TO THE CAUSE OF THIS EVENT. THE REPORTED DRILL SIZE USED WAS APPROPRIATE FOR THE IMPLANT SIZE USED. POTENTIAL CAUSES INCLUDE THE BONE TUNNEL WAS NOT ADEQUATELY PREPPED AND THE SCREW FRACTURED UNDER TORSION OR THE SCREW INSERTION ANGLE WAS DIVERGENT FROM THE DIRECTION OF THE 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 ADDITIONAL RELEVANT INFO IS OBTAINED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, IN AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION CASE, A SCREW WAS BROKEN DURING INSERTION AND NOT RETRIEVED. THE SURGEON WAS DRILLING WITH A DRILL DIAMETER OF 10. THE PT'S BONE DENSITY WAS REPORTED AS NORMAL. FOLLOW-UP WITH THE REPORTER PROVIDED INFO THAT THE SURGEON DRILLED ANOTHER TUNNEL TO PLACE A SECOND IMPLANT; THE CASE WAS COMPLETED WITH ANOTHER SCREW. NO FURTHER PT INFO WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO FOLLOW-UP REQUESTS. 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 SCREW, BIO-INTERFERENCE SHEATHED, 10X23MM MAI ARTHREX, INC. NA 109338

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other INFO REQUESTED BUT NOT PROVIDED.