BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK LUPINE STABILIZATION DRILL BIT

    MDR report key: 3140263 · Received May 31, 2013

    Report

    Report Number
    1221934-2013-00145
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 15, 2013
    Manufacturer
    DEPUY MITEK
    Product Code
    GFG
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NOTHING IS BEING RETURNED FOR EVALUATION, COMPLAINT DEVICES DISCARDED AT USER FACILITY. ALSO NO LOT NUMBER WAS SUPPLIED, WHICH PRECLUDES CONDUCTING A LOT REVIEW. HOWEVER, ALTHOUGH NOTHING IS BEING RETURNED, 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 THEM DUPLICATED. OUTSIDE OF THIS HYPOTHESIS AND CONSIDERATION, WE CANNOT DISCERN ANY OTHER ROOT CAUSE FOR THE REPORTED ISSUE. AT THIS POINT IN TIME, NO CORRECTIVE OR FURTHER ACTION IS WARRANTED, HOWEVER, THIS FILE WILL REMAIN RECEPTIVE TO ANY POTENTIAL FUTURE INFORMATION RECEIVED THAT IS RELATIVE AND GERMANE TO THIS ISSUE. 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.

    Description of Event or Problem · 1

    OUR REP. IS REPORTING TO US THAT DURING AN ARTHROSCOPIC SHOULDER PROCEDURE THE SURGEON OBSERVED METAL FILINGS FALLING INTO THE JOINT SPACE WITH THE USE OF A TWO LUPINE DRILL BIT. ALL OF THE DEBRIS WAS REMOVED FROM THE BODY AND THE PROCEDURE WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT. DEVICES DISCARDED AT USER FACILITY. THEY ARE REPORTING THAT THE DEVICE HAS BEEN IN USE FOR OVER 2 YEARS. ALSO SEE ASSOCIATED MDR 1221934-2013-00144.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242359 MITEK LUPINE STABILIZATION DRILL BIT ARTHROSCOPIC INSTRUMENT GFG DEPUY MITEK NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1