BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOKNOTLESS ANCHOR

    MDR report key: 1007820 · Received March 4, 2008

    Report

    Report Number
    1221934-2008-00111
    Event Type
    Malfunction
    Date Received
    March 4, 2008
    Date of Event
    February 22, 2008
    Report Date
    February 22, 2008
    Manufacturer
    DEPUY MITEK
    Product Code
    MBI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH NOTHING IS 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", 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. WHEN THE DEVICE IS RECEIVED, A FAILURE ANALYSIS WILL BE CONDUCTED, IF THE RESULTS OF SAID INVESTIGATION DIFFER FROM THE ABOVE HYPOTHESIS A FOLLOW UP REPORT REFLECTING THE FAILURE ANALYSIS CONCLUSION WILL BE FILED.

    Description of Event or Problem · 1

    THE SALES REP REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF PROCEDURE, FOUR INSERTERS BROKE DURING ANCHOR INSERTION INTO THE BONE. THE INSERTERS FELL INTO THE PT AND WERE RETRIEVED. THE INSERTERS WERE DISCARDED AND THE ANCHORS REMAINED IN THE PT. A FIFTH LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO PT CONSEQUENCES. FOUR PRODUCTS FROM LOT 3060738 AND ONE FROM LOT 3062768 WERE USED IN THE PROCEDURE, IT IS UNK WHAT PRODUCT LOTS THE BROKEN DEVICES CAME FROM. THE SALES REP STATED THE DOCTOR HAS USED THE PRODUCT FOR SEVEN YEARS AND COMMENTED TO THE REP THAT HE FELT SOMETHING HAD CHANGED WITH THE INSERTERS. SEE ALSO ASSOCIATED MDRS 1221934-2008-00109, 1221934-2008-00110, 1221934-2008-00112 AND 1221934-2008-00113.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOKNOTLESS ANCHOR SOFT TISSUE FIXATION DEVICE MBI DEPUY MITEK 212738 3060738

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK