BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOKNOTLESS ANCHOR + W/PANACRYL

    MDR report key: 1061918 · Received June 16, 2008

    Report

    Report Number
    1221934-2008-00300
    Event Type
    Malfunction
    Date Received
    June 16, 2008
    Date of Event
    June 6, 2008
    Report Date
    June 6, 2008
    Manufacturer
    DEPUY MITEK
    Product Code
    MBI
    Removal / Correction Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE COMPLAINT DEVICE HAS NOT YET BEEN RECEIVED 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 CONCLUSIONS WILL BE FILED.

    Description of Event or Problem · 1

    OUR REP IS REPORTING THAT DURING AN ARTHROSCOPIC SHOULDER REPAIR, A PORTION OF THE DISTAL END OF 2 INSERTERS BROKE OFF WITHIN THEIR RESPECTIVE ANCHORS AND REMAIN CAPTURED IN THE BONE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER INCIDENT OR HARM TO THE PT. ALSO SEE ASSOCIATED MDR 1221934-2008-00301.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOKNOTLESS ANCHOR + W/PANACRYL SOFT TISSUE FIXATION DEVICE MBI DEPUY MITEK 212725 30280352

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK