BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK ARTHROSCOPIC EQUIPMENT

    MDR report key: 2792725 · Received October 16, 2012

    Report

    Report Number
    1221934-2012-00271
    Event Type
    Malfunction
    Date Received
    October 16, 2012
    Date of Event
    October 5, 2012
    Report Date
    October 8, 2012
    Manufacturer
    DEPUY MITEK
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    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. AWAITING DEVICE RETURN.

    Additional Manufacturer Narrative · 1

    (B)(6) DAYS HAVE PASSED SINCE THIS ISSUE WAS REPORTED TO MITEK, AND TO DATE, DESPITE OUTREACHES FOR FURTHER DETAIL AND COMPLAINT DEVICE RETURN, NOTHING HAS BEEN RECEIVED, AND NO ADDITIONAL INFORMATION OTHER THAN WHAT WAS ORIGINALLY REPORTED HAS BEEN RECEIVED. NO LOT NUMBER HAS BEEN 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. WE CANNOT DISCERN A ROOT CAUSE FOR THE REPORTED ISSUE. AT THIS POINT IN TIME, NO FURTHER ACTION IS WARRANTED. HOWEVER, THIS FILE WILL REMAIN RECEPTIVE TO ANY POTENTIAL FORTHCOMING INFORMATION RECEIVED THAT IS PERTINENT 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 KNEE REPAIR, A PORTION OF THE DISTAL TIP OF A HEX DRIVER BROKE OFF INTO THE FIXATION SCREW WHILST THE SURGEON WAS DRIVING THE SCREW INTO THE BONE. THE TIP 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 HXX DEPUY MITEK NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1