BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK LUPINE DOVETAIL DRILL GUIDE

    MDR report key: 3851714 · Received June 5, 2014

    Report

    Report Number
    1221934-2014-00212
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 7, 2014
    Manufacturer
    DEPUY MITEK
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED. VISUAL INSPECTION OF THE DRILL GUIDE REVEALED THE DISTAL TIP IS BENT AND DAMAGED. THIS DEVICE IS 10 YEARS OLD AS APPARENT FROM THE LOT NUMBER. REPEATED USE OF THE DEVICE HAS POSSIBLY LED TO DAMAGE ON THE DISTAL END AND EVENTUALLY CAUSED METAL SHAINGS EMANATING FROM THE DISTAL END. THIS FAILURE CAN BE ATTRIBUTED TO FIELD WEAR. A REVIEW INTO THE DEPUY MITEK COMPLAINTS SYSTEM REVEALED ONE DISSIMILAR COMPLAINT FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. AT THIS POINT IN TIME, NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY 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.

    Additional Manufacturer Narrative · 1

    ATTEMPTS HAVE BEEN MADE TO RETRIEVE ADDITIONAL INFORMATION ABOUT THE EVENT AND DEVICE. THE ADDITIONAL INFORMATION WILL REPORTEDLY BE FORWARDED TO DEPUY MITEK; HOWEVER, IT IS NOT KNOWN IF IT WILL BE RECEIVED WITHIN THE 30 DAY REPORTING REQUIREMENT, THEREFORE, DEPUY MITEK WOULD LIKE TO FILE THIS INITIAL MEDWATCH REPORT AT THIS TIME. WHEN AND IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REFLECTED IN A FOLLOW-UP MEDWATCH REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DISTAL TIP OF THEIR LUPINE DOVE TAIL DRILL GUIDE WAS BENT CAUSING METAL SHAVINGS DURING A SHOULDER PROCEDURE. THE SURGEON REMOVED THE METAL SHAVINGS FROM INSIDE THE PATIENT AND USED ANOTHER SET TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCES OR DELAYS. THE DRILL GUIDE IS COMING BACK FOR EVALUATION. NO FURTHER DETAILS WERE AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DISTAL TIP OF THEIR LUPINE DOVE TAIL DRILL GUIDE WAS BENT CAUSING METAL SHAVINGS DURING A SHOULDER PROCEDURE. THE SURGEON REMOVED THE METAL SHAVINGS FROM INSIDE THE PATIENT AND USED ANOTHER SET TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCES OR DELAYS. THE DRILL GUIDE IS COMING BACK FOR EVALUATION. NO FURTHER DETAILS WERE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328557 MITEK LUPINE DOVETAIL DRILL GUIDE ARTHROSCOPIC ANCHOR INSTRUMENT FZX DEPUY MITEK NA 4I3

    Patients

    Seq Age Sex Outcome Treatment
    1