BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEALIX ADVANCE ORTHOCORD

    MDR report key: 25009125 · Received April 27, 2026

    Report

    Report Number
    1221934-2026-01706
    Event Type
    Malfunction
    Date Received
    April 27, 2026
    Date of Event
    April 17, 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
    Health Professional
    N

    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. 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 ATTACHED TO THE INSERTER AND WAS BROKEN AND CRACKED NEAR MID-BODY. 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 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 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. DOCUMENT SPECIFICATION REVIEW: IFU-100191. DEVICE HISTORY LOT: PN: 222295. LOT NUMBER: 104DP0. THERE WAS NO NON CONFORMANCE REGARDING THIS LOT MANUFACTURING DATE: 31/OCT/2024. EXPIRY DATE: 30/SEP/2027. DEVICE HISTORY BATCH: NULL. E1: THE REPORTER¿S COMPLETE FACILITY ADDRESS WAS NOT PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE THE 4.5 HEALIX ADVANCE BR W/OCORD ANCHOR DEVICE BROKE. ALL THE BROKEN PARTS WERE REMOVED. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. 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. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54753 HEALIX ADVANCE ORTHOCORD FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE MAI DEPUY MITEK LLC US 104DP0 10886705021314

    Patients

    Seq Age Sex Outcome Treatment
    1