BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.5 HEALIX ADVANCE KNTLSS BR

    MDR report key: 8043707 · Received November 6, 2018

    Report

    Report Number
    1221934-2018-55213
    Event Type
    Malfunction
    Date Received
    November 6, 2018
    Date of Event
    October 24, 2018
    Report Date
    October 24, 2018
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    UDI-DI
    10886705023479
    PMA / PMN Number
    K130917
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. UDI: (B)(4). INVESTIGATION SUMMARY: THE COMPLAINT DEVICE WAS DISCARDED BY THE CUSTOMER THEREFORE THE DEVICE IS NOT AVAILABLE FOR A PHYSICAL EVALUATION. THIS COMPLAINT IS NOT CONFIRMED. WITHOUT PHYSICALLY EVALUATING THE DEVICE, A DEFINITE ROOT CAUSE CANNOT BE DETERMINED. NO NONCONFORMANCES WERE IDENTIFIED FOR THIS PART NUMBER (222331), LOT NUMBER (L936821) COMBINATION. THIS FILE WILL REMAIN RECEPTIVE TO ANY POTENTIAL FORTHCOMING INFORMATION RECEIVED THAT IS PERTINENT AND GERMANE TO THIS ISSUE. HOWEVER, DEPUY SYNTHES MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A ROTATOR CUFF REPAIR PROCEDURE THE CUSTOMER'S 5.5MM HEALIX ADVANCE KNOTLESS ANCHOR KITE BROKE WHILE THE SUTURES WERE BEING LOADED ON. THE SALES REP STATED THEY WERE USING A HEALIX ADVANCE AWL AND THERE WERE TWO SUTURES AND FOUR TAILS. THERE WERE NO DEBRIS IN THE PATIENT. THE CASE WAS COMPLETED WITH ANOTHER LIKE-DEVICE IN THE SAME BONE HOLE WITH NO PATIENT HARM, BUT A ONE MINUTE DELAY TO ATTAIN THE NEW ANCHOR. THE ANCHOR WAS DISCARDED BY THE CUSTOMER. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    882914 5.5 HEALIX ADVANCE KNTLSS BR SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI DEPUY MITEK LLC US L936821 10886705023479

    Patients

    Seq Age Sex Outcome Treatment
    1