BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUAL CUT SAGITTAL BLADE

    MDR report key: 1051557 · Received April 29, 2008

    Report

    Report Number
    9616696-2008-00009
    Event Type
    Malfunction
    Date Received
    April 29, 2008
    Date of Event
    April 2, 2008
    Report Date
    April 2, 2008
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    DWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED FOR EVAL. WORK ORDER DOCUMENTATION REVIEWED AND ALL SPECS WERE MET.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TOTAL KNEE PROCEDURE, THE BLADE BROKE. THE BROKEN BLADE DID NOT FALL INTO THE SURGICAL SITE AND THERE WAS NO PT INJURY ASSOCIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUAL CUT SAGITTAL BLADE SAW BLADES AND ACCESSORIES DWH STRYKER INSTRUMENTS 080868017

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK