BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK LUPINE SAW TOOTH DRILL GUIDE

    MDR report key: 3093560 · Received May 6, 2013

    Report

    Report Number
    1221934-2013-00124
    Event Type
    Malfunction
    Date Received
    May 6, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 2, 2013
    Manufacturer
    DEPUY MITEK
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NOTHING IS BEING RETURNED FOR EVALUATION AND NO LOT NUMBER HAS BEEN SUPPLIED. HOWEVER, THE CAUSE FOR THE SHEDDING DEBRIS HAS BEEN IDENTIFIED IN THE COMPLAINT VERBIAGE; THE INWARD BENT TOOTH OF THE DRILL GUIDE. THIS TYPE OF DAMAGE WOULD BE ATTRIBUTED TO HANDLING, A USER ISSUE, WHICH WE SUGGEST HERE TO BE THE ROOT CAUSE OF THE METAL SHAVINGS. AT THIS POINT IN TIME, NO CORRECTIVE OR FURTHER ACTION IS WARRANTED, HOWEVER, THIS FILE WILL REMAIN RECEPTIVE TO ANY POTENTIAL FUTURE INFORMATION RECEIVED THAT IS RELATIVE AND GERMANE TO THIS ISSUE. ALSO, 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.

    Description of Event or Problem · 1

    OUR REP. IS REPORTING TO US THAT DURING AN ARTHROSCOPIC SHOULDER PROCEDURE, THE SURGEON OBSERVED METAL FILINGS FALLING INTO THE JOINT SPACE WITH THE USE OF A LUPINE SAW TOOTH DRILL GUIDE. IT WAS NOTED THAT ONE OF THE TEETH OF THE GUIDE WAS BENT INWARDS CAUSING THE DRILL TO COME INTO CONTACT WITH IT RESULTING IN THE REPORTED METAL SHAVINGS. ALL OF THE DEBRIS WAS REMOVED FROM THE BODY AND THE PROCEDURE WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT. DEVICES DISCARDED AT USER FACILITY. THE COMPLAINT DEVICE WAS DISCARDED AT THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197262 MITEK LUPINE SAW TOOTH DRILL GUIDE ARTHROSCOPIC INSTRUMENT FZX DEPUY MITEK NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1