BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSVERSE DRILL GUIDE

    MDR report key: 1900930 · Received November 10, 2010

    Report

    Report Number
    2936485-2010-00828
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    September 28, 2010
    Report Date
    October 11, 2010
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    LXI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO WILL BE PROVIDED ONCE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TRANSVERSE DRILL GUIDE WAS USED FIRST TIME WHEN THE SCREW JAMMED. IT WAS FURTHER STATED THAT THE SURGEON HAD TO USE FORCEPS TO UNLOCK THE SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSVERSE DRILL GUIDE DRILL GUIDE LXI STRYKER ENDOSCOPY SAN JOSE 34376

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK