BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUPINE DRILL GUIDE

    MDR report key: 1182705 · Received September 25, 2008

    Report

    Report Number
    1221934-2008-00455
    Event Type
    Malfunction
    Date Received
    September 25, 2008
    Date of Event
    September 19, 2008
    Report Date
    September 22, 2008
    Manufacturer
    DEPUY MITEK
    Product Code
    HRX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE BELIEVE THAT THIS TYPE OF EVENT IS MOST LIKELY TECHNIQUE RELATED, EXTENSIVE LAB TESTING HAS SHOWN THAT UNDER NORMAL CONDITIONS THE REPORTED EVENT MODE COULD NOT BE DUPLICATED, HOWEVER, UNDER EXTREME CONDITIONS, THAT IS WHEN THE DRILL GUIDE WAS BENT DURING DRILLING WITH A DRILL BIT, THIS CAUSED THE DRILL BIT TO RUB AGAINST INNER SURFACE OF THE BENT DRILL GUIDE CAUSING SOME METAL TO SHAVE OFF OF THE DRILL GUIDE, THE REPORTED CONDITIONS WAS THEN DUPLICATED. THERE HAS BEEN SOME MANUFACTURING PROCESSES CHANGES MADE TO SUBVERT AND OR GREATLY REDUCE THIS TYPE OF EVENT. THE PHENOMENA IS STILL UNDER STUDY BY THE MITEK QAE GROUP AND WHENEVER POSSIBLE RELATIVE FAILURE MODE DEVICES WILL BE FORWARDED TO THE GROUP TO SUBSIDIZE THEIR STUDY, 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. WHEN AND IF THE COMPLAINT DEVICE(S) IS RECEIVED HERE AT DEPUY MITEK IT WILL BE SUBJECTED TO A ROOT CAUSE FAILURE ANALYSIS. IF THE ANALYSIS IDENTIFIES ANY OTHER DEFINITIVE ROOT CAUSE A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    OUR REP REPORTS THAT DURING AN ARTHROSCOPIC SHOULDER REPAIR, THE SURGEON NOTED THAT WITH THE USE OF THE LUPINE DRILL GUIDE, METAL SHAVINGS WERE FALLING INTO THE PATIENT'S JOINT SPACE. THIS SURGEON SWITCHED DRILL GUIDES, USING 4 DIFFERENT ONES, HOWEVER THE SAME PHENOMENA HAPPENED EACH TIME. ALL OF THE DEBRIS WAS REMOVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT. COMPLAINT DEVICES DISCARDED BY USER FACILITY. ALSO SEE ASSOCIATED MDRS 1221934-2008-00454, 1221934-2008-00456 AND 1221934-2008-00457.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUPINE DRILL GUIDE ARTHROSCOPIC INSTRUMENT HRX DEPUY MITEK 213817 6A3

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK