BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3MM X 8MM, BIO-COMPOSITE TENODESIS SCREW

    MDR report key: 1973539 · Received January 31, 2011

    Report

    Report Number
    1220246-2011-00002
    Event Type
    Injury
    Date Received
    January 31, 2011
    Date of Event
    December 30, 2010
    Report Date
    January 4, 2011
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    PMA / PMN Number
    K051726
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    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. DEVICE HISTORY RECORD REVEALED NOTHING RELEVANT TO THIS EVENT. EVALUATION OF THE RETURNED DEVICE CONFIRMS THE COMPLAINT. THE HEX DRIVE PORTION OF THE DRIVER HAS BROKEN OFF FROM THE SHAFT. THE FRACTURE FACE IS AT AN ANGLE TO THE DISTAL FACE OF THE DRIVER. THE DEVICE MET ALL SPECIFICATIONS AS RECEIVED. THE COMPLAINANTS EVENT WAS MOST LIKELY CAUSED BY PRYING / LEVERAGING THE DRIVER WHILE THE IMPLANT WAS STILL LOADED. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT NUMBER 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 DRIVER TIP HAD BROKEN OFF TWICE WITH BOTH SCREWS DURING ACL REPAIR AND NOT RETRIEVED. DRIVER TIPS WERE LEFT IN PATIENT WITH SCREW FOR BOTH 3X8 SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3MM X 8MM, BIO-COMPOSITE TENODESIS SCREW SCREW, FIXATION, BONE HWC ARTHREX, INC. 351800

    Patients

    Seq Age Sex Outcome Treatment
    1 Other AR-1530BC 3MM X 8MM BIO-COMPOSITE TENODESIS SCREW