BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERSAL DRIVER SHAFT

    MDR report key: 2062584 · Received April 8, 2011

    Report

    Report Number
    2249697-2011-00432
    Event Type
    Injury
    Date Received
    April 8, 2011
    Date of Event
    March 15, 2011
    Report Date
    March 15, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    HXX
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "WHILE INSERTING SECOND SCREW, TIP OF SCREWDRIVER BROKE OFF INTO HEAD OF SCREW. BROKEN TIP WAS RETRIEVED FROM PATIENT. A STRAIGHT SCREWDRIVER WAS USED TO FINISH PUTTING SCREW IN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERSAL DRIVER SHAFT INSTRUMENT HXX STRYKER ORTHOPAEDICS MAHWAH NA FYH532

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention