BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN RADIOLUCENT DRILL BIT

    MDR report key: 2093556 · Received April 5, 2011

    Report

    Report Number
    9616696-2011-00048
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 10, 2011
    Manufacturer
    STRYKER IRELAND LTD.
    Product Code
    GFF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RRAD ATTACHMENT AND RADIOLUCENT DRILL BIT SUBJECT TO THIS INVESTIGATION WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. INVESTIGATION RESULTS INDICATE THAT THE DRILL BIT STALLED IN THE ATTACHMENT AND COULD NOT BE REMOVED. PART NUMBER AND LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED TO PERMIT FURTHER INVESTIGATION. THE ROOT CAUSE IS UNDETERMINED. RRAD ATTACHMENT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA THE SERVICE AND REPAIR DEPARTMENT, THAT THE RADIOLUCENT DRILL BIT WAS STUCK IN THE ATTACHMENT. IT WAS ALSO REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN RADIOLUCENT DRILL BIT GFF STRYKER IRELAND LTD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK