BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6.5 HEALIX ADVANCE KNTLS BR

    MDR report key: 21873659 · Received April 21, 2025

    Report

    Report Number
    1221934-2025-01389
    Event Type
    Malfunction
    Date Received
    April 21, 2025
    Date of Event
    March 7, 2025
    Report Date
    April 21, 2025
    Manufacturer
    MEDOS INTERNATIONAL SàRL
    Product Code
    MAI
    UDI-DI
    10886705030712
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MITEK, 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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. H11: ADDITIONAL NARRATIVE: INVESTIGATION SUMMARY THE COMPLAINT DEVICE WAS DISCARDED BY THE CUSTOMER, THEREFORE NOT RETURNED TO J&J MEDTECH ORTHOPAEDICS AND UNAVAILABLE FOR A PHYSICAL EVALUATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER (242L981), AND NO NON-CONFORMANCE WAS IDENTIFIED. BASED ON THE CURRENT AVAILABLE INFORMATION, WE CANNOT DETERMINE A ROOT CAUSE FOR THE REPORTED FAILURE. IF ADDITIONAL INFORMATION IS RECEIVED IN THE FUTURE, WE WILL REOPEN THE COMPLAINT AND PERFORM THE INVESTIGATION AS APPROPRIATE. IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED AND THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. AS PART OF J&J MEDTECH ORTHOPAEDICS 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

    THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE FOR A ROTATOR CUFF TEAR IN THE RIGHT SHOULDER JOINT, IT WAS DISCOVERED THAT THE TIPS OF THE ANCHORS FROM TWO 6.5 HEALIX ADVANCE KNTLS BR DEVICES HAD CRACKED AND BROKEN. ACCORDING TO THE REPORTER, WHEN THE SURGEON ATTEMPTED TO THREAD ONE DYNA TAPE, ONE DYNA CORD, AND ONE ORTHO CORD THROUGH THE PROXIMAL KITE OF THE DEVICE, AS WELL AS TWO DYNA CORDS AND ONE ORTHO CORD THROUGH THE DISTAL KITE SIMULTANEOUSLY, THE TIP OF THE ANCHOR CRACKED AND BROKE. SINCE THE THREADING WAS PERFORMED OUTSIDE THE BODY, NO BROKEN PIECES WERE LEFT INSIDE. INSTEAD, THE DEVICE WAS EXTRACTED, THE TAPE AND THREADS WERE THREADED IN THE SAME MANNER AND THEN REINSERTED INTO THE BODY. THERE WAS THIRTY-MINUTE DELAY TO THE SURGICAL PROCEDURE. IT WAS NOT REPORTED WHETHER A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1238988 6.5 HEALIX ADVANCE KNTLS BR SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI MEDOS INTERNATIONAL SàRL 242L981 10886705030712

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown