BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAGITTAL BLADE 18.0X1.27X100MM

    MDR report key: 1950142 · Received December 8, 2010

    Report

    Report Number
    9616696-2010-00364
    Event Type
    Malfunction
    Date Received
    December 8, 2010
    Date of Event
    November 10, 2010
    Report Date
    November 11, 2010
    Manufacturer
    STRYKER IRELAND LTD
    Product Code
    GFA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BLADE SUBJECT TO THIS MDR WAS RETURNED FOR EVAL. IT WAS VISUALLY CONFIRMED THAT ONE TAB OF THE MOUNT OF THE BLADE WAS BROKEN. THE RETURNED BLADE WAS MEASURED WHERE POSSIBLE AND ALL CRITICAL SPECIFICATIONS WERE MET. MFG RECORDS WERE REVIEWED, NO ISSUES WERE IDENTIFIED WHICH MAY HAVE CONTRIBUTED TO THIS EVENT. THE ROOT CAUSE IS MULTI-FACTORIAL. HANDPIECE: SYSTEM 5.

    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 THERE WAS A DELAY OF FIVE MINUTES TO THE PROCEDURE AND THE SURGEON HAD NO CONCERNS ABOUT ANY PIECES BEING LEFT BEHIND IN THE PT. IT WAS FURTHER 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 SAGITTAL BLADE 18.0X1.27X100MM SAW BLADES & ACCESSORIES GFA STRYKER IRELAND LTD 10088017

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK