BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DYONICS

    MDR report key: 2082220 · Received April 22, 2011

    Report

    Report Number
    2082220
    Event Type
    Malfunction
    Date Received
    April 22, 2011
    Date of Event
    April 12, 2011
    Report Date
    April 22, 2011
    Manufacturer
    SMITH & NEPHEW ENDOSCOPY
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERGOING SHOULDER SCOPE UTILIZING A SMITH & NEPHEW DYONICS 4.5 MM INCISOR PLUS ELITE BLADE. SURGEON NOTED THE SOUND OF THE ROTATING BLADE WAS NOT NORMAL AND OPTED TO REMOVE THE BLADE FROM USE AND OBTAIN A SECOND DEVICE OF SAME TYPE AND MODEL. UPON USING THE SECOND DEVICE FINE METAL SHAVINGS WERE NOTED TO BE APPEARING IN THE PATIENT'S JOINT. JOINT WAS FLUSHED COPIOUSLY TO REMOVE PARTICLES. BOTH ABOVE REFERENCED SHAVERS WERE FROM THE SAME LOT NUMBER. A THIRD SHAVER (FROM DIFFERENT LOT NUMBER) WAS USED TO COMPLETE THE CASE WITH NO ISSUES NOTED. BOTH DEFECTIVE SHAVERS WERE SEQUESTERED FOR RISK MANAGEMENT PICK UP, UNFORTUNATELY THEY WERE PLACED INTO ONE BAG SO UNABLE TO DETERMINE WHICH ONE PRODUCED SHAVINGS AND WHICH ONE MADE ABNORMAL SOUNDS. NO INJURY TO PATIENT, JUST DELAY AND FRUSTRATION WITH PRODUCT ISSUES.====================== MANUFACTURER RESPONSE FOR (2) 4.5MM INCISOR PLUS ELITE BLADES, DYONICS======================OUR FACILITY HAS FILED 7 PREVIOUS MEDWATCH REPORTS RELATED TO CONCERNS WITH METAL SHAVINGS, AT LEAST TWO FROM THIS PARTICULAR DEVICE, AS WELL AS OTHER SMITH & NEPHEW SHAVERS. TO DATE WE HAVE RECEIVED NO EVALUATION RESULTS FROM THE MANUFACTURER AS TO WHAT MAY BE CAUSING THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DYONICS 4.5MM INCISOR PLUS ELITE BLADES HRX SMITH & NEPHEW ENDOSCOPY 7210976 50573255

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR