BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAGITTAL BLADE 18.0X1.27X100MM

    MDR report key: 2676111 · Received July 26, 2012

    Report

    Report Number
    9616696-2012-00200
    Event Type
    Malfunction
    Date Received
    July 26, 2012
    Date of Event
    June 29, 2012
    Report Date
    June 29, 2012
    Manufacturer
    STRYKER IRELAND LTD.
    Product Code
    GFA
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE BLADE SUBJECT TO THIS MDV WAS RETURNED TO THE MFR FOR EVAL. IT WAS VISUALLY CONFIRMED THAT ONE TAB WAS BROKEN FROM THE MOUNT OF THE BLADE. THE RETURNED PART WAS MEASURED WHERE POSSIBLE AND ALL CRITICAL SPECS WERE MET. 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 SURGICAL PROCEDURE, THE BLADE BROKE AT THE MOUNT. IT WAS ALSO REPORTED THAT A PIECE OF THE BROKEN BLADE FELL INTO THE SURGICAL FIELD. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAGITTAL BLADE 18.0X1.27X100MM GFA STRYKER IRELAND LTD. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK