BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAGITTAL BLADE 25.0X1.27X100MM

    MDR report key: 2093555 · Received April 5, 2011

    Report

    Report Number
    9616696-2011-00047
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    March 9, 2011
    Report Date
    March 9, 2011
    Manufacturer
    STRYKER IRELAND LTD.
    Product Code
    GFA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE BLADE SUBJECT TO THIS MDR WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. LOT NUMBER INFORMATION 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 SURGICAL PROCEDURE ON THE KNEE THAT THE BLADE BROKE AT THE MOUNT. IT WAS ALSO REPORTED THAT THERE WERE NO DELAYS AS A RESULT OF THIS EVENT. 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 25.0X1.27X100MM GFA STRYKER IRELAND LTD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK