BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUPINE DRILL GUIDE

    MDR report key: 1062040 · Received June 13, 2008

    Report

    Report Number
    1221934-2008-00296
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    June 2, 2008
    Report Date
    June 2, 2008
    Manufacturer
    DEPUY MITEK
    Product Code
    HRX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    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 BUT, 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 REC'D 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

    THE SALES REP REPORTED THAT METAL SHAVINGS FROM THE DRILL GUIDE WERE SEEN IN THE PT. ALL OF THE DEBRIS WAS REMOVED FROM THE BODY, THE PROCEDURE WAS CONCLUDED 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 213818 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK