BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIGIDFIX 3.3 ST X PIN KIT

    MDR report key: 1022489 · Received March 31, 2008

    Report

    Report Number
    1221934-2008-00156
    Event Type
    Malfunction
    Date Received
    March 31, 2008
    Date of Event
    March 10, 2008
    Report Date
    March 10, 2008
    Manufacturer
    DEPUY MITEK
    Product Code
    MBI
    Removal / Correction Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE COMPLAINT DEVICE HAS NOT YET BEEN RECEIVED FOR EVALUATION, HISTORICALLY, THIS TYPE OF FAILURE IS ASSOCIATED WITH NOT USING THE PROPER TECHNIQUE TO REMOVE THE GUIDE SLEEVE FROM THE BONE. THE MOST LIKELY SCENARIO IS THAT 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 REVIEW INTO THE MITEK COMPLAINTS SYSTEM REVEALED NO OTHER COMPLAINTS OF ANY KIND FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. ALTHOUGH THE SURGEON FEELS THAT THERE WAS NO INJURY TO THE PT, THE FACT THAT THE BROKEN FRAGMENT WAS NOT RETRIEVED FROM THE PATIENT, POSSES THE POSSIBILITY THAT PATIENT INJURY COULD POTENTIALLY OCCUR. WE DO NOT KNOW WHAT IMPACT, IF ANY; THIS WOULD HAVE ON THE PATIENT. IT IS BECAUSE OF THIS UNCERTAINTY THAT THIS REPORT IS BEING FILED TO DOCUMENT THIS EVENT. WHEN AND IF THE COMPLAINT DEVICE IS RECEIVED HERE AT DEPUY MITEK, IT WILL BE SUBJECTED TO A FAILURE ROOT CAUSE ANALYSIS. IF THE ANALYSIS IDENTIFIES ANY OTHER DEFINITIVE ROOT CAUSE THAT IS DIFFERENT THAN THE ABOVE HYPOTHESIS, A FOLLOW-UP REPORT WILL BE FILED. AT THIS TIME, NO FURTHER ACTION IS REQUIRED. HOWEVER, 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 REPORTS THAT DURING A KNEE PROCEDURE, A PORTION OF THE DISTAL END OF A RIGIDFIX GUIDE SLEEVE BROKE OFF INTO THE PATIENT'S CONDYLE AND REMAINS BURIED THEREIN. THE CASE WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIGIDFIX 3.3 ST X PIN KIT SOFT TISSUE FIXATION DEVICE MBI DEPUY MITEK 210133 2972915

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR