BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUPINE DRILL GUIDE

    MDR report key: 1970015 · Received January 14, 2011

    Report

    Report Number
    1221934-2011-00015
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 23, 2010
    Report Date
    December 23, 2010
    Manufacturer
    DEPUY MITEK
    Product Code
    HRX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOTHING IS BEING RETURNED FOR EVAL; DEVICE DISCARDED AT USER FACILITY, ALSO, NO LOT NUMBER SUPPLIED, WHICH PRECLUDES CONDUCTING A BATCH RECORD REVIEW TO DETERMINE IF THERE WERE ANY INTERNAL PROCESSING ISSUES WHICH WOULD HAVE CONTRIBUTED TO THE NATURE OF THE PRODUCT COMPLAINT. HOWEVER, 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. OUTSIDE OF THIS HYPOTHESIS, WE CANNOT DISCERN ANY OTHER ROOT CAUSE FOR THE REPORTED ISSUE. AT THIS POINT IN TIME, OUTSIDE OF THE FACT THAT 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, NO CORRECTIVE OR FURTHER ACTION IS WARRANTED.

    Description of Event or Problem · 1

    OUR REP IS REPORTING TO US THAT DURING AN ARTHROSCOPIC SHOULDER REPAIR, THE SURGEON NOTED THAT THERE WERE METAL SHAVINGS EMANATING FROM A LUPINE DRILL GUIDE AND FALLING INTO THE JOINT SPACE. ALL OF THE DEBRIS WAS REMOVED FROM THE BODY AND THE PROCEDURE WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PT. COMPLAINT DEVICES DISCARDED AT USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUPINE DRILL GUIDE ARTHROSCOPIC INSTRUMENT HRX DEPUY MITEK 213816 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK