BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK FEMORAL AIMER 5MM OFFSET

    MDR report key: 3010892 · Received March 19, 2013

    Report

    Report Number
    1221934-2013-00067
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 14, 2013
    Manufacturer
    DEPUY MITEK
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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. IN TRANSIT.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RECEIVED AND INSPECTED UNDER MAGNIFICATION. VISUAL OBSERVATIONS INDICATE THE DEVICE TO BE OLD AND HEAVILY USED. THE MARKINGS ON THE DEVICE ARE SLIGHTLY FADED AND RUSTY. THE DISTAL TIP WHEN EXAMINED UNDER MAGNIFICATION REVEALED NICKS AND MARKS CONSISTENT WITH COMING IN CONTACT WITH SHARP METAL INSTRUMENTS. NO BURR OBSERVED AS REPORTED. THERE WAS NO VISUAL INDICATION ON THE DEVICE THAT WOULD SUGGEST THE METAL SHAVINGS EMANATED FROM THIS DEVICE. FURTHERMORE, NO LOT NUMBERS WERE PROVIDED WHICH PRECLUDES CONDUCTING A BATCH HISTORY REVIEW OR A LOT SPECIFIC SEARCH IN THE COMPLAINTS HANDLING SYSTEM. WE CANNOT DETERMINE A DEFINITIVE ROOT CAUSE FOR THIS FAILURE. HOWEVER, DEPUY 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 AFFILIATE REPORTED THAT METAL DEBRIS CAME OFF OF A 5MM OFFSET FEMORAL AIMER DURING USE IN AN ACL RECONSTRUCTION PROCEDURE, WHICH FELL INTO THE PATIENT'S JOINT SPACE. THE DEBRIS WAS REMOVED FROM THE PATIENT WITHIN APPROXIMATELY FIVE MINUTES, AND THE PROCEDURE WAS COMPLETED WITH NO REPORTED HARM OR CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113609 MITEK FEMORAL AIMER 5MM OFFSET ARTHROSCOPIC INSTRUMENTATION LXH DEPUY MITEK 219355 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1