BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUPINE DOVE TAIL DRILL GUIDE

    MDR report key: 2060828 · Received March 11, 2011

    Report

    Report Number
    1221934-2011-00093
    Event Type
    Malfunction
    Date Received
    March 11, 2011
    Date of Event
    February 22, 2011
    Report Date
    February 22, 2011
    Manufacturer
    DEPUY MITEK
    Product Code
    HRX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOTHING IS BEING RETURNED FOR EVALUATION; THE FACILITY DISCARDED THE COMPLAINT DEVICE. NO LOT NUMBER WAS 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. PER PHONE FOLLOW UP CONVERSATION WITH THE MITEK REP, THE REP STATES THAT THE DEVICE IS AROUND 3 YEARS OLD AND HAS SEEN SOME USE. OUTSIDE OF ASSOCIATING THE DEVICE FAILURE TO FAIR WEAR AND TEAR THROUGH AGE/USAGE WE CANNOT DISCERN A ROOT OR UNDERLYING CAUSE FOR THE DEVICE'S FAILURE. AT THIS POINT IN TIME, NO 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 REPAIR, THE SURGEON NOTED THAT A PORTION OF THE DISTAL TIP OF A LUPINE DOVE TAIL DRILL GUIDE BROKE OFF INTO THE PATIENT'S JOINT SPACE. THE FRAGMENT WAS EASILY RETRIEVED AND THE PROCEDURE WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT. THE COMPLAINT DEVICE WAS DISCARDED AT THE USER FACILITY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK