BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAG SCREWDRIVER 380X110MM

    MDR report key: 1884512 · Received October 21, 2010

    Report

    Report Number
    9610622-2010-00450
    Event Type
    Malfunction
    Date Received
    October 21, 2010
    Date of Event
    August 28, 2010
    Report Date
    August 29, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED, LAG SCREW WAS INSERTED INTO THE NAIL AND ADVANCED. LAG SCREW WAS INSERTED INTO VERY HARD BONE AND AT THE POINT OF FINAL ADVANCEMENT SEIZED UP. SURGEON THEN TRIED TO EXTRACT THE SCREW BY UNSCREWING THE NAIL AND THE ANTI ROTATION TABS ON THE INSERTER SNAPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAG SCREWDRIVER 380X110MM INSTRUMENT LXH STRYKER OSTEOSYNTHESIS KIEL NA K712762

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other