BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAGITTAL BLADE

    MDR report key: 2030923 · Received March 21, 2011

    Report

    Report Number
    9616696-2011-00040
    Event Type
    Injury
    Date Received
    March 21, 2011
    Date of Event
    February 22, 2011
    Report Date
    February 23, 2011
    Manufacturer
    STRYKER IRELAND LTD.
    Product Code
    GFA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE BLADE SUBJECT TO THIS MDR WAS NOT RETURNED TO THE MFR FOR EVAL. IT WAS DISCARDED. LOT NUMBER INFO HAS NOT BEEN PROVIDED TO PERMIT FURTHER INVESTIGATION. THE ROOT CAUSE IS MULTI-FACTORIAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TOTAL KNEE PROCEDURE, THE BLADE BROKE AT THE MOUNT. IT WAS ALSO REPORTED THAT AN X-RAY WAS PERFORMED TO LOCATE THE BROKEN PIECES, ONE OF THE BROKEN PIECES WAS NOT RETRIEVED. IT WAS FURTHER REPORTED ANOTHER BLADE WAS READILY AVAILABLE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAGITTAL BLADE SAW BLADES & ACCESSORIES GFA STRYKER IRELAND LTD. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention