BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREWDRIVER SHAFT, SHORT NON-CANN, 2.5MM HEX

    MDR report key: 1860872 · Received October 7, 2010

    Report

    Report Number
    1220246-2010-00186
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    September 13, 2010
    Report Date
    September 13, 2010
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. BROKEN PORTION NOT RETURNED. IT WAS OBSERVED THAT THE REMAINING TIP TWISTED (TORSIONAL FAILURE). MATERIAL ANALYSIS CONFIRMED CORRECT MATERIAL TYPE AND HARDNESS. DEVICE HISTORY RECORD REVEALED NOTHING RELEVANT TO THIS EVENT. BASED ON THE INFORMATION PROVIDED AND DEVICE EVALUATION, THE MOST LIKELY CAUSE(S) OF THIS EVENT IS CONTINUALLY APPLYING TORQUE AFTER THE SCREW IS FULLY SEATED, TORQUING WHEN THE IMPLANT IS NOT PROPERLY ALIGNED, TORQUING WHILE LEVERAGING THE DEVICE AND/OR USING THE INCORRECT SCREW WITH THE DRIVER (SCREW DOES NOT SEAT FULLY ON THE DRIVER). 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 TIP BROKE OFF IN THE SCREW AT THE END OF INSERTION. TIP REMAINS IN SCREW IN PATIENT, TIP IS FLUSH WITH THE SCREW. ACL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREWDRIVER SHAFT, SHORT NON-CANN, 2.5MM HEX ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ARTHREX, INC. 119285

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Other AR-1357( LOW PROFILE CANCELLOUS SCREW AND WASHER)