BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCS ANCHORS

    MDR report key: 457366 · Received April 30, 2003

    Report

    Report Number
    1221934-2003-00032
    Event Type
    Injury
    Date Received
    April 30, 2003
    Date of Event
    September 24, 2002
    Report Date
    March 31, 2003
    Manufacturer
    MITEK WORLDWIDE
    Product Code
    MBI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    A REPORTED INCIDENT ALLEGEDLY INVOLVING AN UNKNOWN MITEK ANCHOR WAS RECEIVED FROM THE PATIENT INVOLVED DETAILING THE FOLLOWING: A ROUTINE SUCCESSFUL ROTATOR CUFF REPAIR WAS PERFORMED IN 2002 AND WAS DESCRIBED AS SUCH BY THE SURGEON WHO HAD PERFORMED THE PROCEDURE. VIDEOS OF THE PROCEDURE WERE VIEWED BY THE SURGEON AND THE PATIENT SHOWING THAT THE ANCHORS IN QUESTION WERE PROPERLY PLACED, WERE INTACT AND THAT THE SUTURES WERE HOLDING THE TENDONS IN PLACE. A POST OPERATIVE PERIOD OF 1 MONTH WAS SPENT BY THE PATIENT AS IMMOBILIZATION OF THE ARM THAT HAD BEEN TREATED AND RESTRICTION TO "PASSIVE MOVEMENT" TO FACILITATE FLEXIBILITY. AT THE END OF THIS 1 MONTH HEALING PROCESS THE PATIENT ENTERED INTO A PHYSICIAN THERAPY PROGRAM TO REGAIN THE USE OF THEIR ARM. THE PATIENT HAD A VERY PAINFUL EXPERIENCE TO THE REHAB THERAPY WHICH DID NOT IMPROVE AS THE THERAPY MOVED FORWARD. 3 MONTHS POST OP AN X-RAY AND 2 MRIS WERE TAKEN WHICH REVEALED WHAT APPEARED TO BE "FAULTY HEALING" OF THE OPERATIONAL AREA. IN 2003, A RE-OPERATION WAS PERFORMED, THIS WAS AN OPEN PROCEDURE WITH APPROXIMATELY A 2" INCISION TO ACCESS THE AREA OF CONCERN. AT THIS POINT THE SURGEON FOUND THAT ONE OF THE ALLEGED UNKNOWN MITEK ANCHORS WAS BROKEN AT THE AREA WHERE THE SUTURE IS ATTACHED TO IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCS ANCHORS BONE ANCHOR MBI MITEK WORLDWIDE UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN