BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIO-TENODESIS SCREW WITH HANDLE INSERTER, 3X8MM

    MDR report key: 1413860 · Received July 10, 2009

    Report

    Report Number
    1220246-2009-00117
    Event Type
    Other
    Date Received
    July 10, 2009
    Date of Event
    June 15, 2009
    Report Date
    June 16, 2009
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    PMA / PMN Number
    K051726
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REQUESTED FOR EVAL, BUT WAS NOT RETURNED BECAUSE IT WAS DISCARDED, THEREFORE, THE COMPLAINANT'S EVENT COULD NOT BE VERIFIED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFO AVAILABLE AND WITHOUT DEVICE EVAL. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. BASED ON THE INFO PROVIDED, THE MOST LIKELY CAUSES OF THIS TYPE OF EVENT ARE PRYING/LEVERAGING THE DRIVER WHILE THE IMPLANT IS STILL LOADED, EXCESSIVE ROTATIONAL FORCE APPLIED WHILE INSERTING THE IMPLANT, PREPARING A PILOT HOLE THAT IS TOO SMALL. A PILOT HOLE THAT IS TOO SMALL MAY COMPRESS THE IMPLANT AROUND THE DRIVER, CREATING DIFFICULTY REMOVING THE DRIVER FROM THE SCREW HEAD. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A WRIST PROCEDURE, THE METAL TIP OF THE DRIVER BROKE OFF AND REMAINS IN THE PT. AFTER THE SURGEON TRANSFERRED A LIGAMENT AND WAS ATTACHING IT TO ONE OF THE CARPAL BONES, THE TIP OF THE DRIVER BROKE WHILE INSERTING THE SCREW. THE SCREW WAS FULLY SEATED; THE SURGEON WAS UNABLE TO RETRIEVE THE METAL TIP OF THE DRIVER FROM THE SCREW. NO FURTHER PT INFO 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIO-TENODESIS SCREW WITH HANDLE INSERTER, 3X8MM HWC ARTHREX, INC. NA 141930

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other INFO REQUESTED BUT NOT PROVIDED.