BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHRO-KNIFE, 2-SIDE POINT

    MDR report key: 1243082 · Received November 21, 2008

    Report

    Report Number
    1017294-2008-00350
    Event Type
    Malfunction
    Date Received
    November 21, 2008
    Date of Event
    October 28, 2008
    Report Date
    November 6, 2008
    Manufacturer
    CONMED LINVATEC
    Product Code
    HTS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: AN INVESTIGATION CONFIRMED THE REPORTED PROBLEM. UPON TESTING OF THE RETURNED UNIT, APPROXIMATELY 1 MM OF THE BLADE DID NOT RETRACT INTO THE SHEATH. DISASSEMBLY FOUND THE LOOP PORTION BROKEN AT THE TRIGGER. CONMED LINVATEC HAS INITIATED A CORRECTIVE ACTION TO ADDRESS THIS FAILURE MODE. THE INSTRUCTIONS FOR USE (IFU) INFORMS THE USER: INSPECT THE KNIFE ASSEMBLY, INCLUDING THE RETRACTABLE SLIDE, FOR DAMAGE (E.G., CRACKS, DENTS) PRIOR TO USE. DO NOT USE IF BLADE DOES NOT FULLY RETRACT. DO NOT USE IF ANY DAMAGE IS NOTICED. PRIOR TO WITHDRAWAL FROM THE SURGICAL SITE, VISUALIZE THE BLADE TIP TO BE SURE IT IS FULLY RETRACTED WITHIN THE SHEATH. INJURY MAY RESULT. SHEATHED ARTHROSCOPY KNIFE BLADE CUTTING SURFACES ARE VERY SHARP. DO NOT INSERT OR REMOVE INSTRUMENT FROM PATIENT WHEN THE BLADE IS EXTENDED OUT OF THE SHEATH. ALWAYS RETRACT THE BLADE WITHIN THE SHEATH PRIOR TO INSERTION OR REMOVAL OF THE INSTRUMENT FROM THE PATIENT. INJURY MAY RESULT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING PRE-OPERATIVE TESTING, WHEN THE ARTHRO-KNIFE BLADE WAS RETRACTED, IT WOULD NOT FULLY RETURN INTO THE SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTHRO-KNIFE, 2-SIDE POINT KNIFE, ORTHOPEDIC HTS CONMED LINVATEC NA BBC49678

    Patients

    Seq Age Sex Outcome Treatment
    1 NK NK