BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSCILLATING AND SAGITTAL BLADE

    MDR report key: 2121724 · Received May 19, 2011

    Report

    Report Number
    9616696-2011-00081
    Event Type
    Malfunction
    Date Received
    May 19, 2011
    Date of Event
    April 19, 2011
    Report Date
    April 22, 2011
    Manufacturer
    STRYKER INSTRUMENTS CORK
    Product Code
    GFA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE TWO BLADES SUBJECT TO THIS INVESTIGATION WERE RETURNED FOR EVAL. IT WAS VISUALLY CONFIRMED THAT THE BLADES BROKE AT THE MOUNT. THE RETURNED BLADES WERE 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 UNDETERMINED. THE LOT NUMBER OF THE SECOND BLADE ASSOCIATES WITH THIS MDR IS AS FOLLOWS: 11052017.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ACL (ANTERIOR CRUCIATE LIGAMENT) PROCEDURE, TWO BLADES BROKE AT THE MOUNT. IT WAS ALSO REPORTED THAT THERE WAS NO PT INJURY AND THERE WAS NO DELAYS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT ANOTHER BLADE WAS READILY AVAILABLE AND THE PROCEDURE WAS COMPETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSCILLATING AND SAGITTAL BLADE GFA STRYKER INSTRUMENTS CORK 10211017

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK