BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.5 HEALIX BR ANCHOR W/ORTHOCORD

    MDR report key: 8744648 · Received June 28, 2019

    Report

    Report Number
    1221934-2019-57463
    Event Type
    Malfunction
    Date Received
    June 28, 2019
    Date of Event
    May 31, 2019
    Report Date
    May 31, 2019
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    UDI-DI
    10886705007769
    PMA / PMN Number
    K150209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL NARRATIVE: INVESTIGATION SUMMARY: THE COMPLAINT DEVICE IS NOT BEING RETURNED, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. THIS COMPLAINT CANNOT BE CONFIRMED. THE SURGEON NOTED THAT MINIMAL PRESSURE WAS APPLIED AND BELIEVED THAT THE KNOT PUSHER MAY HAVE SHARPENED OVER TIME WITH CONSISTENT AND REPETITIVE USE, THEREFORE IS A POSSIBLE ROOT CAUSE OF THE REPORTED ISSUE. THE REPORTED EVENT OCCURRED MOST LIKELY DUE TO THE KNOT PUSHER WHICH IS NOT A MITEK PRODUCT. HOWEVER, WITHOUT THE RETURN OF THE COMPLAINT DEVICE, AND NO FURTHER INFORMATION PROVIDED WE CANNOT DETERMINE A DEFINITIVE ROOT CAUSE. FURTHER, NO LOT NUMBERS WERE SUPPLIED WHICH PRECLUDES CONDUCTING A DEVICE HISTORY RECORD (DHR) REVIEW OR A LOT SPECIFIC SEARCH IN THE COMPLAINTS HANDLING SYSTEM. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. 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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL PROCODES: HTY, JDR, MBI. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. REPORTER IS A MITEK EMPLOYEE. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM AUSTRALIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY/ROTATOR CUFF REPAIR PROCEDURE, THE 4.5MM HEALIX ADVANCE ANCHOR WITH ORTHOCORD WAS IMPLANTED AND PASSING THROUGH THE TISSUE, THEN A KNOT WAS TIED, AND THE KNOT PUSHER WAS USED TO SLIDE THE KNOT DOWN ONTO THE TISSUE. THE SUTURE WAS CUT FROM THE PRESSURE APPLIED TO THE KNOT PUSHER. THE SURGEON NOTED THAT MINIMAL PRESSURE WAS APPLIED AND BELIEVED THAT THE KNOT PUSHER MAY HAVE SHARPENED OVER TIME WITH CONSISTENT, REPETITIVE USE. ANOTHER KNOT PUSHER WAS OPENED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS A TWO (2) MINUTE DELAY IN THE CASE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. THIS REPORT IS FOR A 4.5 HEALIX BR ANCHOR W/ORTHOCORD. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538669 4.5 HEALIX BR ANCHOR W/ORTHOCORD FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE MAI DEPUY MITEK LLC US 222229 10886705007769

    Patients

    Seq Age Sex Outcome Treatment
    1