BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IBO BLADE, LEFT/RIGHT

    MDR report key: 2061448 · Received March 15, 2011

    Report

    Report Number
    9616696-2011-00036
    Event Type
    Malfunction
    Date Received
    March 15, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 16, 2011
    Manufacturer
    STRYKER IRELAND LTD.
    Product Code
    GFA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BLADE SUBJECT TO THIS INVESTIGATION WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. MANUFACTURING RECORDS WERE REVIEWED, NO ISSUES WERE IDENTIFIED WHICH MAY HAVE CONTRIBUTED TO THIS EVENT. THE ROOT CAUSE IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ORAL MAX SURGERY FOR A SAGITTAL SPLIT OSTEOTOMY CASE, THE BLADE BROKE AT THE WELD BETWEEN THE BLADE AND THE SHANK. IT WAS FURTHER REPORTED THAT THE BROKEN PIECE WAS REMOVED FROM THE SURGICAL SITE AND THE SURGEON HAS NO CONCERNS ABOUT ANY PIECES BEING LEFT BEHIND IN THE PATIENT. IT WAS ALSO REPORTED THAT ANOTHER BLADE WAS READILY AVAILABLE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IBO BLADE, LEFT/RIGHT SAW BLADES & ACCESSORIES GFA STRYKER IRELAND LTD. 10327017

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK