BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEEK PUSHLOCK, 3.5MM X 19.5MM

    MDR report key: 1860746 · Received October 7, 2010

    Report

    Report Number
    1220246-2010-00187
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    September 8, 2010
    Report Date
    September 14, 2010
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    PMA / PMN Number
    K061863
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 RECEIVED AND AN EVALUATION WAS CONDUCTED. THE COMPLAINT WAS CONFIRMED. THE MOST LIKELY CAUSE(S) OF THIS TYPE OF EVENT INCLUDE PREPARING A PILOT HOLE THAT IS TOO SMALL, INSERTING THE IMPLANT AT AN ANGLE THAT IS NOT CO-AXIAL TO THE PILOT HOLE, OR IMPACTING THE IMPLANT BEFORE THE DISTAL IMPLANT (LASER LINE) IS FLUSH WITH THE SURFACE OF THE PILOT HOLE. DEVICE HISTORY RECORD REVEALED NOTHING RELEVANT TO THIS EVENT. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AS SURGEON WENT TO MALLET IN THE ANCHOR IT BEGAN TO SHEAR OFF THE SIDE AND WOULD NOT GO INTO THE BONE. HE TRIED ANOTHER LOT NUMBER, SHEARED AGAIN. REPAIR WAS ABANDONED AND A TENOTOMY WAS PERFORMED. LEFT SHOULDER SLAP REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEEK PUSHLOCK, 3.5MM X 19.5MM SCREW, FIXATION, BONE HWC ARTHREX, INC. 253470 AND 253471

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other