BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK RIGIDFIX BONE TENDON BONE 2.7MM CROSS PIN KIT

    MDR report key: 3023410 · Received March 27, 2013

    Report

    Report Number
    1221934-2013-00080
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    September 12, 2012
    Report Date
    March 19, 2013
    Manufacturer
    DEPUY MITEK
    Product Code
    MAI
    PMA / PMN Number
    K974291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 RETURN.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RECEIVED AND VISUALLY EVALUATED; BOTH WITH THE NAKED EYE AND UNDER MAGNIFICATION. THE DEVICE'S CONDITION; DISTAL END BROKEN OFF, BREAK AREA IS TWISTED, TORN AND MALFORMED, CAN ONLY BE ATTRIBUTED TO THE FOLLOWING: THE USER EITHER DID NOT USE THE PROPER SLEEVE REMOVAL TOOL AND/OR THE USER TORQUED THE DEVICE FROM SIDE TO SIDE AS OPPOSED TO PULLING STRAIGHT OUT TO REMOVE IT, CAUSING THE METAL OF THE GUIDE TUBE TO FATIGUE AND FAIL, BREAK OFF. A BATCH RECORD REVIEW HAS BEEN CONDUCTED TO DETERMINE IF THERE WERE ANY INTERNAL PROCESSING ISSUES WHICH WOULD HAVE CONTRIBUTED TO THE NATURE OF THE PRODUCT COMPLAINT. OUR RESULTS INDICATE THAT THIS BATCH OF PRODUCT WAS PROCESSED WITHOUT INCIDENT AND THEREFORE THERE IS NO INTERNALLY ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM. FURTHER, A REVIEW INTO THE MITEK COMPLAINTS SYSTEM REVEALED NO OTHER COMPLAINTS OF ANY KIND FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. 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.

    Description of Event or Problem · 1

    MITEK RECEIVED ON (B)(6) 2013, A 3500 FROM THE FDA WHICH WAS AUTHORED BY THE USER FACILITY ON (B)(6) 2012. THE AUTHOR REPORTS THAT DURING A KNEE REPAIR WITH THE USE OF MITEK RIGIDFIX FOR FIXATION, A PORTION OF THE DRILL SLEEVE BROKE OFF INTO THE PATIENT'S CONDYLE. THE FRAGMENT WAS RETRIEVED FROM THE BODY AND VERIFIED VIA IMAGING. THE PROCEDURE WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126022 MITEK RIGIDFIX BONE TENDON BONE 2.7MM CROSS PIN KIT SOFT TISSU FIXATION DEVICE MAI DEPUY MITEK NA 3620231

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR