BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUPINE DRILL GUIDE

    MDR report key: 1511722 · Received October 5, 2009

    Report

    Report Number
    1221934-2009-00389
    Event Type
    Malfunction
    Date Received
    October 5, 2009
    Date of Event
    July 8, 2009
    Report Date
    July 8, 2009
    Manufacturer
    DEPUY MITEK
    Product Code
    HRX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH OUR AFFILIATE AND ITS ACCOUNT HAVE REPORTED THE INSERTER MECHANISM OF A LUPINE LOOP ANCHOR, CATALOG #222980, WE HAVE DISCOUNTED THIS DEVICE AS THE PRECIPITATING ELEMENT FOR THE REPORTED METAL SHAVINGS ISSUE. AFTER SEVERAL CALL AND RESPONSE E-MAILS WITH OUR AFFILIATE, WE ARE ATTRIBUTING THE METAL SHAVINGS TO AN UNDEFINED LUPINE DRILL GUIDE. WE MAKE THIS ATTRIBUTION BASED ON HISTORICAL EVIDENCE OF EMPIRICAL OBSERVATIONS, VOCAL ADMISSIONS, LONG TERM STUDIES AND EXTENSIVE LAB TESTING. 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 OR DEFLECTED DURING DRILLING WITH A DRILL BIT, THIS CAUSED THE DRILL BIT TO RUB AGAINST INNER SURFACE OF THE BENT/DEFLECTED DRILL GUIDE CAUSING SOME METAL TO SHAVE OFF OF THE DRILL GUIDE, THE REPORTED CONDITION 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. OUTSIDE OF THIS, NO FURTHER ACTION IS WARRANTED.

    Description of Event or Problem · 1

    OUR AFFILIATE IS REPORTING THAT DURING AN ARTHROSCOPIC SHOULDER REPAIR, METAL SHAVINGS WERE OBSERVED EMANATING FROM A LUPINE DRILL GUIDE, AND FALLING INTO THE PT'S JOINT SPACE. ALL OF THE DEBRIS WAS REMOVED FROM THE BODY AND THE PROCEDURE WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER INCIDENT OR HARM TO THE PT. COMPLAINT DEVICE DISCARDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK