BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUPINE DRILL GUIDE

    MDR report key: 1022477 · Received March 31, 2008

    Report

    Report Number
    1221934-2008-00171
    Event Type
    Malfunction
    Date Received
    March 31, 2008
    Date of Event
    March 19, 2008
    Report Date
    March 27, 2008
    Manufacturer
    DEPUY MITEK
    Product Code
    HRX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 CONDITION 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 AND IF THE COMPLAINT DEVICE IS RECEIVED HERE AT MITEK, IT WILL BE DISCARDED AS THE REPORTED PHENOMENON IS ACKNOWLEDGED AND IS IN THE PROCESS OF BEING ADDRESSED.

    Description of Event or Problem · 1

    OUR REP IS REPORTING THAT DURING AN ARTHROSCOPIC SHOULDER REPAIR, THE SURGEON OBSERVED METAL SHAVINGS THAT WERE EMANATING FROM THE DRILL GUIDE AND FALLING INTO THE PT'S JOINT SPACE. ALL OF THE DEBRIS WAS REMOVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER INCIDENT OR HARM TO THE PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK