BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULATED DRILL 4.9MM FOR SCREWS 6.5MM LARGE AO

    MDR report key: 1495803 · Received August 27, 2009

    Report

    Report Number
    8031020-2009-00078
    Event Type
    Malfunction
    Date Received
    August 27, 2009
    Date of Event
    August 1, 2009
    Report Date
    August 3, 2009
    Manufacturer
    STRYKER OSTEOSYNTHESIS SELZACH
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INSTRUMENT WAS DISPOSABLE. WILL NOT BE RETURNED. IF THE DEVICE OR ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AS THE DRILL BIT PASSED OVER THE GUIDE WIRE, THE GUIDE WIRE BECAME LODGED INSIDE OF THE DRILL BIT. AS DRILL BIT WAS REMOVED, THE GUIDE WIRE CAME OUT WITH IT. HAD TO GET THE GUIDE WIRE OUT OF DRILL BIT AND THEN FIND THE HOLE IT CAME OUT OF, AND TRY TO REINSERT THE GUIDE WIRE WHERE IT WAS PREVIOUSLY WHICH IS WHAT WE DID. NO ADVERSE CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CANNULATED DRILL 4.9MM FOR SCREWS 6.5MM LARGE AO INSTRUMENT HTW STRYKER OSTEOSYNTHESIS SELZACH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other