BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOKNOTLESS ANCHOR

    MDR report key: 1190654 · Received October 6, 2008

    Report

    Report Number
    1221934-2008-00473
    Event Type
    Malfunction
    Date Received
    October 6, 2008
    Date of Event
    September 30, 2008
    Report Date
    September 30, 2008
    Manufacturer
    DEPUY MITEK
    Product Code
    MBI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE COMPLAINT DEVICE IS NOT BEING RETURNED FOR A FAILURE ANALYSIS, THIS TYPE OF FAILURE HAS HISTORICALLY BEEN ATTRIBUTED TO USER TECHNIQUE. FROM AN ENGINEERING PERSPECTIVE, DAMAGE TO THE INSERTER, "TIP BREAKAGE" OR "SHAFT BENDING", MAY HAVE BEEN CAUSED BY OFF-ANGLE OR OFF AXIS INSERTION INTO THE BONE HOLE. OFF ANGLE/AXIS INSERTION IS THE MOST LIKELY CAUSE FOR THE INSERTER DISTAL TIP FAILURE, USUALLY THE RESULT OF BENDING AND/OR TWISTING THE ANCHOR DURING DEPLOYMENT DUE TO ANCHOR / BONE HOLE MISALIGNMENT. THE IFU STATES NOT TO TWIST AND/OR BEND THE INSERTER UPON INSERTION AS THE ANCHOR, SUTURE AND/OR INSERTER TIP MAY BE DAMAGED. MITEK IS AWARE OF AND ACKNOWLEDGES THIS PROBLEMATIC ISSUE. THE PHENOMENA IS UNDER STUDY BY THE MITEK QAE GROUP AND WHENEVER POSSIBLE RELATIVE FAILURE MODE DEVICES WILL BE FORWARDED TO THE GROUP TO SUBSIDIZE THEIR STUDY, 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. WHEN AND IF THE COMPLAINT DEVICE(S) IS RECEIVED HERE AT DEPUY MITEK, IT WILL BE SUBJECTED TO A ROOT CAUSE FAILURE ANALYSIS. IF THE ANALYSIS IDENTIFIES ANY OTHER DEFINITIVE ROOT CAUSE, A FOLLOW-UP REPORT WILL BE FILED. OUTSIDE OF THIS, NO FURTHER ACTIONS ARE WARRANTED AT THIS TIME. 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 REPORTS THAT DURING AN ARTHROSCOPIC SHOULDER REPAIR, A PORTION OF THE DISTAL TIP OF AN INSERTER BROKE OFF INTO ITS INSERTED ANCHOR AND REMAINS THEREIN CAPTURED IN THE BONE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER INCIDENT OR HARM TO THE PATIENT. COMPLAINT DEVICES DISCARDED BY USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOKNOTLESS ANCHOR SOFT TISSUE FIXATION DEVICE MBI DEPUY MITEK 212725 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK