BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUPINE DRILL BIT

    MDR report key: 1182703 · Received September 25, 2008

    Report

    Report Number
    1221934-2008-00453
    Event Type
    Malfunction
    Date Received
    September 25, 2008
    Date of Event
    September 22, 2008
    Report Date
    September 22, 2008
    Manufacturer
    DEPUY MITEK
    Product Code
    HTW
    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. THIS PHENOMENA HAS BEEN THE SUBJECT OF A LONG AND CONSIDERABLE STUDY. AT THIS POINT IN TIME, THE ENGINEERING DESIGN AND THE QUALITY ENGINEERING TEAMS ARE IN THE MIDST OF DEVELOPING SOME DESIGN CHANGES TO SUBVERT AND OR GREATLY REDUCE THIS TYPE OF EVENT. 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 THE COMPLAINT DEVICE IS RECEIVED HERE AT DEPUY MITEK, IT WILL BE FORWARDED TO QUALITY AND DESIGN ENGINEERING, WHERE IT WILL BE SUBJECTED TO A ROOT CAUSE FAILURE ANALYSIS AND ALSO SUPPORT THE ONGOING STUDY OF THIS FAILURE MODE. IF THE ANALYSIS IDENTIFIES ANY 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 BIT, METAL SHAVINGS WERE FALLING INTO THE PATIENT'S JOINT SPACE. ALL OF THE DEBRIS WAS REMOVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUPINE DRILL BIT ARTHROSCOPIC INSTRUMENT HTW DEPUY MITEK 211033 08D

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK