BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIO-PUSHLOCK 3.5MM X 14MM

    MDR report key: 1212767 · Received October 24, 2008

    Report

    Report Number
    1220246-2008-00214
    Event Type
    Other
    Date Received
    October 24, 2008
    Date of Event
    September 11, 2008
    Report Date
    October 3, 2008
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    PMA / PMN Number
    K003816
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED FOR EVALUATION; THE COMPLAINANT'S EVENT WAS CONFIRMED. THE ANCHOR WAS RETURNED; THE DRIVER AND PEEK EYELET WERE NOT RETURNED. VISUAL INSPECTION OF THE ANCHOR REVEALED THE PROXIMAL END WAS DAMAGED AND THE DISTAL PORTION WAS BROKEN/SPLIT APPROXIMATELY DOWN THE MIDDLE. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. THE MOST LIKELY CAUSE OF THIS EVENT IS, WHEN INITIALLY INSERTING THE DEVICE INTO THE PRE-DRILLED PILOT HOLE, THE EYELET TIP IS NOT FULLY SEATED (NOT BOTTOMED OUT IN THE PILOT HOLE) PRIOR TO IMPACTING TO INSERT THE IMPLANT. WHEN THIS HAPPENS, THE IMPLANT DOES NOT SIT FLUSH AGAINST THE EYELET. BECAUSE THE EYELET IS NOT AT THE CORRECT DEPTH, THE IMPLANT (WHEN IMPACTED) WILL SIT PROUD (NOT FLUSH WITH THE BONE). IF IMPACTION CONTINUES AT THIS POINT TO FULLY INSERT THE DEVICE, THE DISTAL END OF THE IMPLANT BECOMES JAMMED AGAINST THE EYELET AND EVENTUALLY SPLITS. 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 PROXIMAL PORTION OF THE ANCHOR BROKE UPON INSERTION (UPON MALLETING). THE ANCHOR WAS RETRIEVED; THE EYELET REMAINED IN THE PATIENT. SURGEON INDICATED THE EYELET WAS DEEPLY EMBEDDED IN BONE AND COULD NOT BE RETRIEVED. THE INSERTER HANDLE WAS DISCARDED. FOLLOW-UP WITH THE REPORTER PROVIDED INFO THAT THE TYPE OF PROCEDURE WAS A BANKART; INSERTION SITE WAS THE SHOULDER GLENOID. THE DEPTH OF IMPLANT WAS REPORTED AS ¼ SEATED; QUALITY OF BONE AS AVERAGE. NO FURTHER PATIENT INFO WAS PROVIDED AT THE TIME OF THIS REPORT, OR MADE AVAILABLE IN RESPONSE TO FOLLOW-UP 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-PUSHLOCK 3.5MM X 14MM HWC ARTHREX, INC. NA 142306

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other AR-1912 DRILL WAS USED IN THE CASE