BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.0 MM AGGRESSIVE PLUS CUTTER, FORMULA (5BX)

    MDR report key: 2062401 · Received April 6, 2011

    Report

    Report Number
    2648666-2011-00091
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    March 22, 2011
    Report Date
    March 22, 2011
    Manufacturer
    STRYKER ENDOSCOPY PUERTO RICO
    Product Code
    HRX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SHORTLY AFTER THE START OF KNEE SURGERY ON THE PATIENT, THE FIRST COGS OF THE UNIT RUBBED OFF AND THE REMAINING COGS BECAME ENTANGLED IN THE TISSUE. IT WAS FURTHER REPORTED THAT THIS MADE IT DIFFICULT TO REMOVE THE BLADE FROM THE JOINT AND PREPARATION OF THE TISSUE BECAME NECESSARY. THE PREPARATION INCLUDED CUTTING THE TISSUE ENTANGLED AROUND THE BLADE WITH A SECOND UNIT IN ORDER TO SEPARATE THE BLADE FROM THE TISSUE IN ORDER TO REMOVE THE BLADE FROM THE KNEE. IT WAS FURTHER REPORTED THAT THE SURGERY WAS COMPLETED WITH AN ALTERNATE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4.0 MM AGGRESSIVE PLUS CUTTER, FORMULA (5BX) CUTTER HRX STRYKER ENDOSCOPY PUERTO RICO 11019CE2

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention