BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK GRYPHON DRILL BIT

    MDR report key: 2875290 · Received December 17, 2012

    Report

    Report Number
    1221934-2012-00339
    Event Type
    Malfunction
    Date Received
    December 17, 2012
    Date of Event
    November 21, 2012
    Report Date
    November 21, 2012
    Manufacturer
    DEPUY MITEK
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE COMPLAINT DEVICE HAS NOT YET BEEN RECEIVED, BASED ON THE EVENT DESCRIPTION, WE ATTRIBUTE THE ISSUE AND THE DEVICE'S CONDITION TO TECHNIQUE, A USER PROBLEM. IF AND WHEN THE DEVICE IS RECEIVED, IT WILL BE SUBJECTED TO A FAILURE ANALYSIS; IF THAT ANALYSIS DIFFERS FROM THE ABOVE CONCLUSION, THEN THIS FILE WILL BE MADE TO REFLECT THOSE CONCLUSIONS AND A FOLLOW-UP REPORT WITH THE UPDATED INFORMATION WILL BE SUBMITTED. 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. DEVICE EVALUATED BY MFR: AWAITING RETURN.

    Description of Event or Problem · 1

    OUR REP IS REPORTING TO US THAT DURING A SHOULDER PROCEDURE WITH THE USE OF A GRYPHON DRILL BIT, THE SURGEON EXPERIENCED SOME USAGE ISSUES, WHICH RESULTED IN METAL SHAVING BEING DEPOSITED INTO THE WOUND. IT APPEARS THAT IN THE SURGEON'S ATTEMPT TO DRILL THE SECOND BONE HOLE HE RAN INTO THE 1ST FIXATION THAT HE HAD JUST DEPLOYED INTO THE BONE, WHICH CAUSED SOME METAL SHAVINGS TO EMANATE FROM THE GRYPHON DRILL BIT AND DRILL GUIDE. THE SURGEON APPARENTLY USED THE SAME INSTRUMENTATION FOR THE 3RD BONE HOLE WITH THE SAME ISSUE, METAL SHAVINGS BEING DEPOSITED INTO THE WOUND. ALL OF THE DEBRIS WAS ABLE TO BE REMOVED AND THE PROCEDURE WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT. ALSO SEE ASSOCIATED MDR 1221934-2012-00340.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MITEK GRYPHON DRILL BIT ARTHROSCOPIC INSTRUMENT LXH DEPUY MITEK NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1