BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREWDRIVER FOR SCREW JACK

    MDR report key: 2883474 · Received November 14, 2012

    Report

    Report Number
    9610726-2012-00354
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 29, 2012
    Report Date
    October 29, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THE SUBJECT DEVICE IS NOT SOLD IN THE U.S., BUT A SIMILAR DEVICE IS COMMERCIALLY AVAILABLE IN THE U.S.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDLE OF THE DRIVER WAS BROKEN WHEN THE SURGEON TRIED TO REMOVE THE SCREW FROM THE FEMORAL COMPONENT THOUGH HE DID NOT APPLY MUCH FORCE. SO, HE USED THE ONLY THE TIP OF THE DRIVER AND JACOBS CHUCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREWDRIVER FOR SCREW JACK INSTRUMENT LXH STRYKER ORTHOPAEDICS LIMERICK NA K367585

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other