BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK FMS 4.0MM ROUND BUR

    MDR report key: 1885062 · Received October 20, 2010

    Report

    Report Number
    1221934-2010-00391
    Event Type
    Malfunction
    Date Received
    October 20, 2010
    Date of Event
    September 16, 2010
    Report Date
    September 16, 2010
    Manufacturer
    DEPUY MITEK
    Product Code
    HRX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED VISUALLY AND FUNCTIONALLY. A TOTAL OF 9 DEVICES WERE RECEIVED; 8 NEW NOT YET USED AND 1 USED DEVICE, HOWEVER, OUR AFFILIATE STATES THE USED DEVICE IS THE COMPLAINT DEVICE: THE FACILITY WANTED TO RETURN THE LOT OF THE STOCK THAT THEY HAD ON HAND. VISUALLY, IT IS NOTED THAT THE COMPLAINT DEVICE HAS FRICTION OR RIFLING MARKS ON THE SURFACE OF THE INNER BLADE AND ON THE INSIDE SURFACE OF THE OUTER SHEATH, INDICATING THAT BOTH SURFACES CAME INTO CONTACT WITH EACH OTHER WHILE THE BLADE WAS IN MOTION OR UNDER USE. ALSO, THE 5 RE-USE INDICATOR TABS WERE MISSING, INDICATING THAT THE DEVICE HAD BEEN REUSED AT LEAST 5 TIMES. FUNCTIONALLY, THE DEVICE WAS ROTATED ON ITS OWN AXIS BY HAND TO SEE IF THEY WOULD PERFORM STRAIGHT AND TRUE; WITHOUT MAKING CONTACT WITH EACH OTHER; NO ABNORMALITIES OR DEFECT IN FUNCTION NOTED. A BATCH RECORD REVIEW HAS BEEN CONDUCTED TO DETERMINE IF THERE WERE ANY INTERNAL PROCESSING ISSUES WHICH WOULD HAVE CONTRIBUTED TO THE NATURE OF THE PRODUCT COMPLAINT. OUR RESULTS INDICATE THAT THIS BATCH OF PRODUCT WAS PROCESSED WITHOUT INCIDENT AND THEREFORE THERE IS NO INTERNALLY ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM. WE CANNOT DISCERN A ROOT CAUSE FOR THE REPORTED ISSUE OR THE CONDITION OF THE COMPLAINT DEVICE. AT THIS POINT IN TIME, NO CORRECTIVE OR FURTHER ACTION IS WARRANTED, HOWEVER, MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD. NO CORRECTIVE OR PREVENTATIVE ACTION IS REQUIRED OR WARRANTED AT THIS TIME.

    Description of Event or Problem · 1

    OUR AFFILIATE IS REPORTING THAT DURING ARTHROSCOPIC PROCEDURES THE SURGEON NOTED METAL SHAVINGS EMANATING FROM 2 FMS SHAVER BURS AND FALLING INTO THE JOINT SPACE. IT IS NOT KNOWN IF ALL OF THE DEBRIS WAS ABLE TO BE REMOVED FROM THE BODY. HOWEVER, THE PROCEDURE WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT. ALSO SEE ASSOCIATED MDR 1221934-2010-00392.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MITEK FMS 4.0MM ROUND BUR ARTHROSCOPIC INSTRUMENT HRX DEPUY MITEK 287750 0427

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK