BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.5 HEALIX ADVANCE BR3SUT W/OC

    MDR report key: 8654784 · Received May 30, 2019

    Report

    Report Number
    1221934-2019-57237
    Event Type
    Malfunction
    Date Received
    May 30, 2019
    Date of Event
    May 8, 2019
    Report Date
    May 8, 2019
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    UDI-DI
    10886705021345
    PMA / PMN Number
    K120078
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. INVESTIGATION SUMMARY: THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED. ONLY TWO PIECES OF SUTURES WERE SENT BACK FOR EVALUATION AND NOT THE ANCHOR. IT CAN BE CONFIRMED THAT THE SUTURES WERE DAMAGED. IT WAS REPORTED THAT THE SUTURES WERE BROKEN ON ONE ANCHOR THAT WAS IMPLANTED ON THE OUTER SIDE. ONE POSSIBLE HYPOTHESIS IS THAT THE INSERTER WAS OFF AXIS AFTER THE ANCHOR WAS IMPLANTED, CAUSING THE SUTURE TO BE DAMAGED BY THE EDGES OF THE INSERTER. AS THE INSERTER WAS NOT SENT BACK, THIS POSSIBILITY CANNOT BE CONFIRMED AT THIS TIME. OTHER THAN THIS POSSIBILITY, WE CANNOT DISCERN A ROOT CAUSE FOR THIS FAILURE.A NON-CONFORMANCE SEARCH WAS PERFORMED AND NO NON-CONFORMANCES WERE IDENTIFIED FOR THIS PART NUMBER (222298) WITH LOT NUMBER (L854981 ) COMBINATION PER QLINK SEARCH PERFORMED ON 7/26/2019. 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. UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. 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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. UDI: (B)(4). AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. 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

    IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A ROTATOR CUFF REPAIR PROCEDURE THE 5.5 HEALIX ADVANCE THREE-SUTURE ANCHOR WITH ORTHOCORD THREE SUTURES WERE BROKEN ON ONE ANCHOR THAT WAS IMPLANTED ON THE OUTER SIDE. THE ISSUE WAS NOTICED AFTER SUTURING THE ROTATOR CUFF AND RETURNING THE PATIENT'S ARM TO THE MIDDLE POSITION. THE LOT NUMBER FOR THE PRODUCT WAS NOT CLEAR AS THREE LOTS OF THE SAME PRODUCT CODE WERE USED IN THIS CASE. IT WAS BRAND NEW AND FIRST USE WHEN THE ISSUE OCCURRED. THERE WAS LESS THAN A THIRTY MINUTE SURGICAL DELAY AND NO HARM TO THE PATIENT. IT WAS REPORTED THAT THE IMPLANT WAS REMOVED FROM THE PATIENT. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449150 5.5 HEALIX ADVANCE BR3SUT W/OC SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI DEPUY MITEK LLC US L854981 10886705021345

    Patients

    Seq Age Sex Outcome Treatment
    1