BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOKNOTLESS ANCHORS

    MDR report key: 1001866 · Received February 25, 2008

    Report

    Report Number
    1221934-2008-00092
    Event Type
    Malfunction
    Date Received
    February 25, 2008
    Date of Event
    February 20, 2008
    Report Date
    February 20, 2008
    Manufacturer
    DEPUY MITEK
    Product Code
    MBI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SURGEON ATTEMPTED TO PERFORM AN ANCILLARY PROCEDURE TO THE PLANNED ROTATOR CUFF REPAIR. AT THE TIME OF THE SURGERY, THE SURGEON WAS VISUALLY REVIEWING THE PT'S JOINT SPACE IN ANTICIPATION OF PERFORMING THE SCHEDULED REPAIR. AT THIS VISUALIZATION, THE SURGEON NOTED SOME MINOR A TYPICAL ABNORMALITIES, LESIONS. THE SURGEON IN GOOD FAITH THOUGHT THAT SINCE HE WAS IN THE JOINT SPACE, HE WOULD TAKE AN EXCURSION FROM THE RC REPAIR TO FIX THE ABNORMALITIES VIA A SLAP/BANKART PROCEDURE WITH THE USE OF 2 SOFT TISSUE FIXATIONS DEVICES. THIS PROVED TO BE FRUITLESS BECAUSE OF THE DEVICE SUTURE FAILURES. THE SURGEON ABANDONED THE EXCURSION, DID NOT FEEL THAT THIS ISSUE WOULD IMPACT THE PT IN ANY WAY. THE ORIGINAL SCHEDULED REPAIR WAS COMPLETED SUCCESSFULLY. AT THIS POINT IN TIME, NO FURTHER ACTION IS WARRANTED. HOWEVER, MITEK WILL CONDUCT A BUILD RECORDS REVIEW TO DETERMINE IF THERE WERE ANY INTERNAL PROCESSING ISSUES WHICH WOULD HAVE CONTRIBUTED TO THE NATURE OF THE PRODUCT COMPLAINT. IF THE RESULTS OF THE BUILD REVIEW INDICATE ANY ABNORMALITIES THAT MAY HAVE INFLUENCED THE REPORTED FAILURE MODE, THOSE DETAILS WILL BE THE SUBJECT OF A F/U REPORT.

    Description of Event or Problem · 1

    OUR REP REPORTS THAT DURING A SCHEDULED ARTHROSCOPIC RC REPAIR ON A MALE, THE SURGEON NOTED SOME ABNORMALITIES IN THE PT'S SHOULDER THAT PROMPTED THE SURGEON TO ATTEMPT A SLAP/BANKART PROCEDURE IN ADDITION TO THE RC REPAIR. THE SURGEON EMPLOYED 2 BIOKNOTLESS ANCHORS FOR THE S/B PORTION OF THE SHOULDER REPAIR, AFTER DEPLOYMENT, BOTH SUTURES OF THE BIOKNOTLESS ANCHORS BROKE. AT THIS POINT, THE SURGEON LEFT THE ANCHORS WITHIN THEIR BONE HOLES AND CHOSE TO ABANDON THE S/B, MOVED ON AND REPAIRED THE RC SUCCESSFULLY WITHOUT FURTHER INCIDENT OR HARM TO THE PT. ALSO SEE ASSOCIATED MDR 1221934-2008-00093.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOKNOTLESS ANCHORS SOFT TISSUE FIXATION DEVICE MBI DEPUY MITEK 212725 3013185

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR