BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREWDRIVER, T10 HEXALOBE

    MDR report key: 1841897 · Received September 23, 2010

    Report

    Report Number
    1220246-2010-00174
    Event Type
    Injury
    Date Received
    September 23, 2010
    Date of Event
    August 19, 2010
    Report Date
    August 24, 2010
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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. LOT NUMBER WAS REQUESTED BUT NOT PROVIDED, THEREFORE DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. BASED ON THE INFORMATION PROVIDED, THE MOST LIKELY CAUSE(S) OF THIS TYPE OF EVENT IS FLEXING THE JOINT DURING INSERTION OF THE IMPLANT WITH THE DRIVER ENGAGED OR PRYING/LEVERAGING THE DRIVER WHILE THE IMPLANT IS STILL LOADED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF DRIVER BROKE OFF IN SCREW. REMAINS IN PATIENT. SURGERY COMPLETED SUCCESSFULLY. OPEN REDUCTION INTERNAL FIXATION. NO FURTHER PATIENT OR EVENT INFORMATION WAS PROVIDED, AT THE TIME THIS EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREWDRIVER, T10 HEXALOBE ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ARTHREX, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other