BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIO-COMP TENODESIS SCREW W/HANDLED INSERTER 3X8MM

    MDR report key: 2217426 · Received August 19, 2011

    Report

    Report Number
    1220246-2011-00128
    Event Type
    Injury
    Date Received
    August 19, 2011
    Date of Event
    June 14, 2011
    Report Date
    July 27, 2011
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    PMA / PMN Number
    K051726
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHICS (AGE AT TIME OF EVENT, DATE OF BIRTH, GENDER, WEIGHT) WERE REQUESTED BUT NOT PROVIDED. 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. DEVICE HISTORY RECORD REVEALED NOTHING RELEVANT TO THIS EVENT. EVALUATION OF THE RETURNED DRIVER REVEALED THAT THE DISTAL HEX DRIVE FEATURE BROKE OFF THE DRIVER. THE DEVICE BROKE AT AN ANGLE INDICATING SHEAR STRESS MOST LIKELY AS A RESULT OF LEVERAGING. THE DEVICE MET ALL MATERIAL SPECIFICATIONS AS RECEIVED. THE COMPLAINANT'S EVENT IS MOST LIKELY CAUSED BY PRYING/LEVERAGING THE DRIVER WHILE THE IMPLANT IS STILL LOADED. THIS IS THE SECOND 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

    PART OF INSERTER BROKE DURING SURGERY AND BROKEN PIECE REMAINED IN PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIO-COMP TENODESIS SCREW W/HANDLED INSERTER 3X8MM SCREW, FIXATION, BONE HWC ARTHREX, INC. 360805

    Patients

    Seq Age Sex Outcome Treatment
    1 Other