BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METAFIX

    MDR report key: 20331524 · Received September 30, 2024

    Report

    Report Number
    9614209-2024-00380
    Event Type
    Malfunction
    Date Received
    September 30, 2024
    Date of Event
    September 16, 2024
    Report Date
    December 13, 2024
    Manufacturer
    CORIN LTD
    Product Code
    LZO
    PMA / PMN Number
    K153381
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). FINAL REPORT THE SURGERY WAS NOT DELAYED AND THERE WAS NO IMPACT TO THE PATIENT. THE SPIGOT ON THE BROACH BROKE WHILST IN SITU, HOWEVER, THE SURGEON WAS ABLE TO RETRIEVE IT WITH PLYERS. THE DEVICE WAS RETURNED, EXAMINED AND THE FAILURE WAS CONFIRMED. THE APPROPRIATE DEVICE DETAILS WERE PROVIDED AND THE RELEVANT DEVICE MANUFACTURING RECORDS HAVE BEEN IDENTIFIED AND REVIEWED. REVIEW OF THESE RECORDS REVEALED NO PRODUCT NON-CONFORMITY OR DEVIATION FROM PROCESS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THIS EVENT. CORIN HAS ONLY RECEIVED FIVE OTHER REPORTS OF THIS FAILURE MODE FOR THE METAFIX BROACHES AND THUS IS A VERY LOW OCCURRENCE. AS THE PART WAS 7 YEARS AND 2 MONTHS OLD AT THE TIME OF THE EVENT, THE ROOT CAUSE IS ESTABLISHED TO BE WEAR AND TEAR CAUSED BY REPEATED AND INTENDED USE. PLEASE NOTE: THIS REPORT IS FILED WITH THE FDA DUE TO AN ADVERSE EVENT EXPERIENCED WITH A DEVICE THAT IS SIMILAR TO THOSE PLACED ON THE MARKET IN THE USA, HOWEVER, THIS EVENT OCCURRED OUTSIDE OF THE USA. THE SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, REPORTING ENTITY, ENTITY'S REPRESENTATIVE OR DISTRIBUTOR CAUSED OR CONTRIBUTED TO THIS EVENT.

    Additional Manufacturer Narrative · 0

    PER -7841 INITIAL REPORT. THE RETURN OF THE DEVICE HAS BEEN REQUESTED IN ORDER TO PROGRESS WITH THE INVESTIGATION OF THIS EVENT, AND IF RECEIVED, WILL BE EXAMINED AND THE RESULTS WILL BE SUPPLIED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. THE APPROPRIATE DEVICE DETAILS WERE PROVIDED AND THE RELEVANT DEVICE MANUFACTURING RECORDS HAVE BEEN IDENTIFIED AND REVIEWED. REVIEW OF THESE RECORDS REVEALED NO PRODUCT NON-CONFORMITY OR DEVIATION FROM PROCESS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THIS EVENT. PLEASE NOTE: THIS REPORT IS FILED WITH THE FDA DUE TO AN ADVERSE EVENT EXPERIENCED WITH A DEVICE THAT IS SIMILAR TO THOSE PLACED ON THE MARKET IN THE USA, HOWEVER, THIS EVENT OCCURRED OUTSIDE OF THE USA. THE SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, REPORTING ENTITY, ENTITY'S REPRESENTATIVE OR DISTRIBUTOR CAUSED OR CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 0

    METAFIX MALE BROACH: THE SPIGOT SNAPPED OFF DURING USE. PLYERS WERE USED TO RETRIEVE THE DEVICE FROM THE PATIENT FEMUR.

    Description of Event or Problem · 0

    METAFIX MALE BROACH: THE SPIGOT SNAPPED OFF DURING USE. PLYERS WERE USED TO RETRIEVE THE DEVICE FROM THE PATIENT FEMUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    962560 METAFIX METAFIX MALE BROACH SIZE 4 LZO CORIN LTD 340.434H 075590-05

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown