BEUDAMED
    FDA Adverse Event Summary report: N

    RIGIDFIX 2.7MM BTB CROSSPIN

    MDR report key: 1981791 · Received January 20, 2011

    Report

    Report Number
    1221934-2011-00021
    Date Received
    January 20, 2011
    Date of Event
    January 10, 2011
    Report Date
    January 13, 2011
    Manufacturer
    DEPUY MITEK
    Product Code
    MAI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH, THE COMPLAINT DEVICE IS NOT BEING RETURNED 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 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 TIME NO CORRECTIVE OR 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 TO US THAT DURING AN ARTHROSCOPIC KNEE REPAIR; A PORTION OF THE DISTAL END OF A RIGIDFIX GUIDE SLEEVE BROKE OFF INTO THE PATIENT'S CONDYLE. THE FRAGMENT WAS NOT ABLE TO BE RETRIEVED FROM THE BONE. THE PROCEDURE WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT. COMPLAINT DEVICE DISCARDED AT USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIGIDFIX 2.7MM BTB CROSSPIN SOFT TISSUE FIXATION DEVICE MAI DEPUY MITEK 210127 3300218

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK