BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUPINE FISH MOUTH DRILL GUIDE

    MDR report key: 2062276 · Received March 18, 2011

    Report

    Report Number
    1221934-2011-00126
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    March 11, 2011
    Report Date
    March 16, 2011
    Manufacturer
    DEPUY MITEK
    Product Code
    HRX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH NOTHING IS BEING RETURNED FOR EVAL, WE BELIEVE 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 CONDITION, 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 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, 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 SHAVINGS FALLING INTO THE PT'S BODY WITH THE USE OF A LUPINE DRILL GUIDE. ALL OF THE DEBRIS WAS REMOVED AND THE PROCEDURE WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PT. THE COMPLAINT DEVICES WERE DISCARDED AT THE USER FACILITY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK