BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUPINE DRILL GUIDE

    MDR report key: 979119 · Received January 15, 2008

    Report

    Report Number
    1221934-2008-00022
    Event Type
    Malfunction
    Date Received
    January 15, 2008
    Report Date
    January 11, 2008
    Manufacturer
    DEPUY MITEK
    Product Code
    HRX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE BELIEVE THAT THIS TYPE OF EVENT IS MOST LIKELY TECHNIQUE RELATED. THIS FAILURE MODE HAS BEEN STUDIED EXTENSIVELY BY THE QUALITY ENGINEERS AND IT HAS BEEN CONCLUDED THAT WHEN THE DRILL GUIDE IS BENT BY EXCESSIVE MECHANICAL FORCE DURING DRILLING WITH A DRILL BIT, THE DRILL BIT RUBS AGAINST INNER SURFACE OF THE BENT DRILL GUIDE CAUSING SOME METAL TO SHAVE OFF OF THE DRILL GUIDE. AT THIS TIME, THERE HAS BEEN SOME DESIGN CHANGES PROPOSED TO SUBVERT AND OR GREATLY REDUCE THIS TYPE OF EVENT. NO FURTHER ACTION IS WARRANTED AT THIS TIME, HOWEVER, 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

    THE SALES REP STATES THAT A SURGEON REPORTED THAT ON 4 SEPARATE OCCASIONS DURING 2008, WHILE USING LUPINE DRILL GUIDES DURING ARTHROSCOPIC SHOULDER REPAIRS PROCEDURE, HE NOTED METAL SHAVINGS EMANATING FROM THE GUIDES INTO THE PATIENTS' JOINT SPACES. IN EACH CASE, ALL OF THE DEBRIS WAS REMOVED AND THE REPAIRS WERE CONCLUDED SUCCESSFULLY WITHOUT FURTHER INCIDENT OR HARM TO THE PT. SURGEON STATES THAT THIS PHENOMENON HAPPENED 2X WITH GUIDE #213817 AND 2X WITH GUIDE 213818. SEE ALSO ASSOCIATED MDRS 1221934-2008-00021, -00023 & -00024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUPINE DRILL GUIDE ARTHROSCOPIC INSTRUMENT HRX DEPUY MITEK 213817 6L1

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK