BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREWDRIVER SHAFT, SHORT NON-CANN, 2.5MM HEX

    MDR report key: 1981156 · Received February 8, 2011

    Report

    Report Number
    1220246-2011-00011
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    January 12, 2011
    Report Date
    January 13, 2011
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 REQUESTED/IS EXPECTED FOR EVALUATION BUT HAS NOT YET BEEN RECEIVED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. DEVICE HISTORY RECORD REVEALED NOTHING RELEVANT TO THIS EVENT. COMPLAINANT'S EVENT TYPICALLY CAUSED BY 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 NUMBER COMBINATION. THE POTENTIAL CAUSES OF THIS EVENT ARE BEING COMMUNICATED TO THE EVENT REPORTER. IF THE DEVICE IS RETURNED AND ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    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. COMPLAINT EVALUATION REVEALED BROKEN TIP. VISUAL EVALUATION OF THE RETURNED DEVICE REVEALED THE HEX TIP BROKE OFF AT APPROXIMATELY 200IN FROM DISTAL END. REMAINING TIP TWISTED. NO OTHER ANOMALIES WERE OBSERVED. COMPLAINANT'S EVENT TYPICALLY CAUSED BY 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). DEVICE MET ALL SPECIFICATIONS AS RECEIVED. 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

    DRIVER TIP HAS BROKEN OFF IN SCREW. DURING AN ACL (L) , THE DRIVER TIP HAS BROKEN OFF IN THE SCREW ON THE LAST TURN. SURGEON CHOSE TO LEAVE IT IN PLACE DUE TO BEING A METAL SCREW AND A VERY TIGHT FIT WITH DRIVER TIP.

    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.

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Other