BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.5 HEALIX ADVANCE BR W/OCORD

    MDR report key: 24208511 · Received January 29, 2026

    Report

    Report Number
    1221934-2026-00443
    Event Type
    Malfunction
    Date Received
    January 29, 2026
    Date of Event
    January 14, 2026
    Report Date
    January 29, 2026
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    UDI-DI
    10886705021314
    PMA / PMN Number
    K120078
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, 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 REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. H11. ADDITIONAL NARRATIVE: AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED, AND NO CONCLUSION CAN BE DRAWN AT THIS TIME. E1: THE REPORTER¿S COMPLETE FACILITY NAME AND ADDRESS WERE NOT PROVIDED. THE PRODUCT WAS NOT RETURNED TO DEPUY SYNTHES; HOWEVER, A PHOTO WAS PROVIDED FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED PHOTO FOUND THAT THE DEVICE HAD THE ANCHOR WITH THE SUTURE DETACHED FROM THE INSERTER AND BROKEN VERTICALLY FROM THE PROXIMAL TO THE DISTAL END. THE DEVICE HAD FOREIGN MATTER, PRESUMABLY BIOLOGICAL MATTER. NO OTHER ANOMALIES WERE NOTED. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF 4.5 HEALIX ADVANCE BR W/OCORD WOULD HAVE CONTRIBUTED TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, THE POTENTIAL CAUSE IS TRACED TO THE PROCEDURAL VARIABLES, SUCH HANDLING OF THE DEVICE OR PRODUCT INTERACTION DURING PROCEDURE. THE POSSIBLE ROOT CAUSE CAN BE ASSOCIATED WITH OFF AXIS INSERTION AND LEVERING DURING INSERTION. AS PER IFU-100191, 1) INSERTING THE AWL OR DRILL TO LESS THAN THE SPECIFIED DEPTH, AXIAL MISALIGNMENT OR LEVERING WITH THE ANCHOR UPON INSERTION MAY RESULT IN ANCHOR FRACTURE. 2) DO NOT APPLY A BENDING FORCE TO THE INSERTER. THIS CAN DAMAGE THE ANCHOR OR INSERTER TIP. 3) APPLY TENSION (NORMAL FORCE) ON SUTURE LENGTHS. EXCESSIVE FORCE MAY OVERLOAD THE ANCHOR OR SUTURE. PROPERLY HANDLING AND ATTENTION TO THE APPROVED USE OF THE DEVICE DIMINISHES THE RISK OF FAILURE. IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. AS PART OF J&J DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING ROTATOR CUFF REPAIR SURGERY, THE 4.5 HEALIX ADVANCE BR W/OCORD BROKE AND ALL THE BROKEN PARTS WERE REMOVED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273828 4.5 HEALIX ADVANCE BR W/OCORD FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE MAI DEPUY MITEK LLC US 104SDC 10886705021314

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown