BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SPIRALOK ANCHOR

    MDR report key: 868454 · Received June 21, 2007

    Report

    Report Number
    1221934-2007-00147
    Event Type
    Injury
    Date Received
    June 21, 2007
    Date of Event
    June 12, 2007
    Report Date
    June 21, 2007
    Manufacturer
    DEPUY MITEK
    Product Code
    MBI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE IS NOT BEING RETURNED, THEREFORE, IS UNAVAILABLE FOR EVALUATION. THE LOT NUMBERS OF THE EXACT ANCHORS THAT BROKE POST-OPERATIVELY ARE UNKNOWN, HOWEVER, BATCH RECORD REVIEWS WERE PERFORMED ON ALL THREE LOT NUMBERS INVOLVED IN THE REPAIR (2991707, 2993528, 2965402) TO DETERMINE IF THERE WERE ANY INTERNAL PROCESSING ISSUES, WHICH WOULD HAVE CONTRIBUTED TO THE NATURE OF THE PRODUCT COMPLAINT. OUR RESULTS INDICATE THAT THESE BATCHES OF PRODUCT WERE 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 THESE LOTS OF 796, 798, AND 200 DEVICES THAT WERE RELEASED TO DISTRIBUTION. THIS TYPE OF FAILURE HAS HISTORICALLY BEEN ATTRIBUTED TO USER TECHNIQUE. ONE HYPOTHESIS IS THAT DURING THE INITIAL ANCHOR INSERTION, THE ANCHOR COULD HAVE BEEN INSERTED OFF AXIS OR INSERTED INTO TOO HARD OR DENSE BONE. ANY ONE OF THESE IMPROPER TECHNIQUES COULD HAVE CREATED A CRACK OR WEAKENED THE ANCHOR DURING INITIAL INSERTION, LEADING TO THE FAILURE OF THE DEVICE OVER TIME. THEREFORE, NO OTHER ROOT-CAUSE CAN BE DETERMINED OTHER THAN THOSE CAUTIONED AGAINST IN THE IFU. WE BELIEVE THIS TO BE A USER TECHNIQUE ISSUE. NO FURTHER ACTION IS WARRANTED AT THIS TIME.

    Description of Event or Problem · 1

    THE REP IS REPORTING THAT TWO OUT OF FOUR SPIRALOK ANCHORS PLACED DURING THE ORIGINAL REPAIR BROKE POST-OPERATIVELY, CAUSING THE REPAIR TO FAIL AND THE NEED FOR A REVISION SURGERY IN 2007. THE FIRST ANCHOR BROKE BELOW THE TOP THREAD AND THE SECOND ANCHOR BROKE BELOW THE EYELET. TO COMPLETE THE REPAIR, THE SURGEON PLACED MORE SPIRALOK ANCHORS DURING THE REVISION SURGERY WITHOUT FURTHER INCIDENT OR HARM TO THE PATIENT (SEE ALSO ASSOCIATED MDR 1221934-2007-00146)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN SPIRALOK ANCHOR SOFT TISSUE FIXATION DEVICE MBI DEPUY MITEK UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention