BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK ARTHROSCOPIC EQUIPMENT

    MDR report key: 2492359 · Received March 15, 2012

    Report

    Report Number
    1221934-2012-00061
    Event Type
    Malfunction
    Date Received
    March 15, 2012
    Date of Event
    February 17, 2012
    Report Date
    February 17, 2012
    Manufacturer
    DEPUY MITEK
    Product Code
    GEF
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED; THE QUALITY ENGINEERING DEPARTMENT INVESTIGATED THE DEVICE'S CONDITION, TIP BREAKAGE, AND CAME TO THE CONCLUSION THAT THE MOST LIKELY CAUSE FOR THE BREAKAGE WAS OFF AXIS SIDE LOAD TO THE DEVICE WHILE ATTEMPTING TO DEPLOY THE SHEATH INTO THE BONE TUNNEL. OUTSIDE OF THAT CONSIDERATION WE CANNOT DISCERN ANY OTHER ROOT CAUSE FOR THE DEVICE'S CONDITION. 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.

    Description of Event or Problem · 1

    OUR AFFILIATE IS REPORTING TO US THAT DURING AN ARTHROSCOPIC KNEE REPAIR, A PORTION OF THE DISTAL TIP OF AN INTRAFIX TIBIAL SHEATH INSERTER BROKE OFF INTO THE SHEATH WHILST THE SURGEON WAS INSERTING THE SHEATH INTO THE BONE TUNNEL. THE FRAGMENT WAS EASILY RETRIEVED FROM THE BODY 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
    1 MITEK ARTHROSCOPIC EQUIPMENT ACL INSTRUMENTS GEF DEPUY MITEK NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1