BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTIFIX KNOTLESS FIXATION DEVICE

    MDR report key: 4801804 · Received May 26, 2015

    Report

    Report Number
    3006524618-2015-00083
    Event Type
    Malfunction
    Date Received
    May 26, 2015
    Date of Event
    April 29, 2015
    Report Date
    November 10, 2015
    Manufacturer
    ARTHORCARE CORP
    Product Code
    MBI
    PMA / PMN Number
    K120096
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE AN EXACT ROOT CAUSE CANNOT BE DETERMINED WITH CONFIDENCE. BASED ON COMPLAINT INFORMATION, THE ANCHOR BROKE ON INSERTION. POTENTIAL ROOT CAUSE FOR THE FAILURE IS MOST LIKELY ATTRIBUTABLE TO USER NOT ADHERING THE IFU, RESULTING IN INCORRECT ALIGNMENT OF THE DEVICE AND BONE HOLE, INCORRECT BONE PREPARATION OR EXCESSIVE PROBING. IFU CONTAINS THE FOLLOWING WARNINGS AND PRECAUTIONARY STATEMENTS: - DO NOT BEND OR TWIST THE INSERTER HANDLE DURING AND AFTER INSERTION AS DAMAGE TO THE IMPLANT OR INCOMPLETE INSERTION MAY RESULT. DO NOT DEPLOY A BENT OR DAMAGED IMPLANT. - A HIGH LEVEL OF SURGICAL SKILL IS REQUIRED FOR IMPLANTATION. A SURGEON SHOULD NOT BEGIN CLINICAL USE OF THE DEVICE WITHOUT FIRST REVIEWING THE INSTRUCTIONS FOR USE AND HAVING PRACTICED THE PROCEDURE IN A SKILLS LABORATORY. - CAUTION: WHEN REQUIRED, USE ONLY A 3.3MM DRILL (OM-9410) OR A 3.4MM PUNCH (OM-9420). USE OF OTHER DRILL BITS OR PUNCHES MAY COMPROMISE IMPLANT INSERTION AND/OR RETENTION. - WARNING: CARE MUST BE TAKEN TO AVOID CREATION OF A SHALLOW BONE HOLE. A PROPER HOLE DEPTH IS ACCOMPLISHED WHEN THE SHOULDER ON THE DRILL OR PUNCH IS ADVANCED TO REACH THE BONE SURFACE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SHOULDER PROCEDURE USING A MULTI-FIX KNOTLESS FIXATION DEVICE, THE ANCHOR BROKE UPON INSERTION. A NEW BONE HOLE WAS DRILLED AND THE PROCEDURE WAS COMPLETED USING A BACKUP DEVICE. THERE WERE NO SIGNIFICANT DELAYS OR PT COMPLAINTS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340888 MULTIFIX KNOTLESS FIXATION DEVICE FIXATION ANCHOR , LIGAMENT, NON-BIODEGRAD MBI ARTHORCARE CORP 1083884

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other