BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL DRIVER SHAFT

    MDR report key: 2140566 · Received June 16, 2011

    Report

    Report Number
    2249697-2011-00893
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 17, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS RETAINED BY THE OPERATING ROOM DIRECTOR FOR THEIR RECORDS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON WAS INSERTING A CANCELLOUS BONE SCREW INTO THE ACETABULAR CUP. AS HE WAS TIGHTENING THE SCREW, THE UNIVERSAL SCREW DRIVER SHAFT TIP BROKE OFF AND THE TIP WAS NOT ABLE TO BE TAKEN OUT OF THE CANCELLOUS BONE SCREW. THE SURGEON WAS FORCED TO LEAVE THE SCREW DRIVER TIP IN THE SCREW AND IMPLANT THE ACETABULAR LINER INTO THE CUP AND AGAIN WITH THE SCREW DRIVER TIP REMAINING IN THE SCREW. THIS RESULTED IN A DELAY IN THE SURGERY AND THE UNKNOWN POSSIBILITY THAT THIS BROKEN SCREW DRIVER TIP COULD CAUSE HARM TO THE TOTAL HIP CONSTRUCT AND THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERSAL DRIVER SHAFT INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA F3W7106

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other