BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK DRIVER EA

    MDR report key: 3021765 · Received March 26, 2013

    Report

    Report Number
    1221934-2013-00079
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    March 22, 2013
    Report Date
    March 22, 2013
    Manufacturer
    DEPUY MITEK
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE (THE DRIVER AND ITS BROKEN TIP FRAGMENT) WAS RECEIVED AND VISUALLY EVALUATED; BOTH WITH THE NAKED EYE AND UNDER MAGNIFICATION. IT IS NOTED THAT THE CONDITION OF THE FRAGMENT, THE HEX PORTION OF THE DRIVER, IS SLIGHTLY DEFORMED AND ROTATIONALLY TWISTED TO A DEGREE. THE COMPLAINT STATES THAT THE SURGEON WAS REMOVING A PREVIOUSLY DEPLOYED FIXATION DEVICE; WE CANNOT SPEAK TO THE DEGREE IN WHICH THE FIXATION DEVICE WAS ANCHORED IN THE BONE BECAUSE OF THE PASSAGE OF TIME AND BONE GROWTH; HOWEVER, THE COMPLAINT DEVICE IS MANUFACTURED AND INTENDED TO DRIVE THE FIXATION SCREW INTO A PREPARED BONE HOLE, NOT INTENDED TO REMOVE A DEVICE WHICH MAYBE WELL ANCHORED. THE CONDITION OF THE FRAGMENT SUGGEST THAT CONSIDERABLE MECHANICAL FORCE WAS APPLIED, ENOUGH TO FAIL THE DEVICE. WE ATTRIBUTE THE DEVICE¿S FAILURE TO THE CIRCUMSTANCE OF USAGE. 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.

    Additional Manufacturer Narrative · 1

    MITEK IS AT THIS POINT IN TIME IN THE INFORMATION GATHERING MODE. WHEN ALL THAT CAN BE HAD, IS HAD AND THOROUGHLY INVESTIGATED AND EVALUATED, THOSE RESULTS WILL BE THE SUBJECT MATTER IN A FOLLOW-UP REPORT. (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTING TO US THAT DURING A REVISION ARTHROSCOPIC KNEE REPAIR, WHILE REMOVING THE PREVIOUSLY INSTALLED FIXATION SCREW, A PORTION OF THE DISTAL TIP OF A DRIVER BROKE OFF INTO THE SCREW WHILST THE SURGEON WAS BACKING THE FIXATION DEVICE OUT OF THE BONE TUNNEL. THE FRAGMENT WAS RETRIEVED AND THE PROCEDURE WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123504 MITEK DRIVER EA ARTHROSCOPIC INSTRUMENT LXH DEPUY MITEK NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1