BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRAFX ADVBR SCW 8X23W/SMSHTH

    MDR report key: 19730430 · Received July 12, 2024

    Report

    Report Number
    1221934-2024-02421
    Event Type
    Malfunction
    Date Received
    July 12, 2024
    Date of Event
    July 4, 2024
    Report Date
    July 12, 2024
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    MAI
    UDI-DI
    10886705026661
    PMA / PMN Number
    K160804
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 DEPUY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY 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. H11 ADDITIONAL NARRATIVE: THE PRODUCT HAS NOT RETURNED TO DEPUY SYNTHES MITEK, HOWEVER A PHOTO WAS PROVIDED FOR REVIEW. THE PHOTO INVESTIGATION REVEALED THAT INTRAFX ADVBR SCW 8X23W/SMSHTH ANCHOR WAS BROKEN. THE ANCHOR HAD FOREIGN MATTER, PRESUMABLY BIOLOGICAL MATTER. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF INTRAFX ADVBR SCW 8X23W/SMSHTH WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, THE POTENTIAL CAUSE FOR THE BROKEN ANCHOR CAN BE TRACED TO OFF AXIS INSERTION AND LEVERING DURING INSERTION. AS PER IFU USE INSTRUCTIONS ARE PROVIDED, AND 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 COMPLAINT CONDITION. AS PART OF DEPUY SYNTHES MITEK 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. H4: THE DEVICE MANUFACTURE DATE WAS UNKNOWN. UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE SALES REP THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2024 THE INTRAFX ADVBR SCW 8X23W/SMSHTH DEVICE WAS BROKEN. THE INTERFACE NAIL WAS BROKEN OFF DURING IMPLANTATION AND ALL THE BROKEN PARTS WERE REMOVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235528 INTRAFX ADVBR SCW 8X23W/SMSHTH FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE MAI MEDOS INTERNATIONAL SARL 179L147 10886705026661

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown