BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DYONICS

    MDR report key: 1915801 · Received November 12, 2010

    Report

    Report Number
    1915801
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 12, 2010
    Manufacturer
    SMITH AND NEPHEW
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US

    Narratives

    Description of Event or Problem · 1

    ELDERLY FEMALE PATIENT WAS TAKEN TO THE OR FOR LEFT KNEE ARTHROSCOPY. DURING THE PROCEDURE IT WAS NOTED THE SMITH & NEPHEW DYONICS 4.5MM TURBOTRIMMER BLADE (SHAVER) APPEARED TO BE PRODUCING SMALL METALLIC SHAVINGS. OR STAFF CHANGED OUT THE SHAVER BLADE AND PROCEEDED WITH THE CASE WITH NO FURTHER ISSUES NOTED. STAFF REPORT IT APPEARED SHAVINGS WERE WASHED OUT OF KNEE CAPSULE AND THE SURGEON DID NOT DIRECT STAFF TO DO ANYTHING ELSE IN REGARDS TO THIS. PATIENT WAS SENT TO THE PACU FOR RECOVERY AND WAS DISCHARGED HOME. THE DEVICE WAS RETAINED AND SEQUESTERED FOR RISK MANAGEMENT PICK UP. OF NOTE, WE HAVE HAD REPORTS OF THIS PREVIOUSLY WITH OTHER DEVICES FROM OTHER MANUFACTURERS AND WAS TOLD THIS MAY BE "LUBRICANT" FLAKING OFF. WE HAVE ALSO SEEN THIS ISSUE WITH REPROCESSED SHAVERS FROM THIS SAME MANUFACTURER. NO APPARENT INJURY OR IMPACT TO PATIENT.======================HEALTH PROFESSIONAL'S IMPRESSION======================POSSIBLY LUBRICANT PARTICLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DYONICS ARTHROSCOPE, SHAVER, BLADE HRX SMITH AND NEPHEW 7205315 50541073

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR