BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARAGON

    MDR report key: 22802139 · Received August 14, 2025

    Report

    Report Number
    9614209-2025-00548
    Event Type
    Malfunction
    Date Received
    August 14, 2025
    Date of Event
    July 25, 2025
    Report Date
    October 10, 2025
    Manufacturer
    CORIN LTD
    Product Code
    LZO
    PMA / PMN Number
    K123782
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PER-(B)(4) FINAL REPORT THE AFFECTED DEVICE WAS RETURNED FOR EVALUATION. THE APPROPRIATE DEVICE DETAILS WERE PROVIDED, AND THE RELEVANT DEVICE MANUFACTURING RECORDS HAVE BEEN IDENTIFIED AND REVIEWED. IT WAS FOUND THAT THE FINISHED PART ASSOCIATED WITH THIS COMPLAINT CONFORMED TO MATERIAL AND DIMENSIONAL SPECIFICATION AT THE TIME OF MANUFACTURE AND NO ANOMALIES WERE OBSERVED ON THE LOT RECORDS THAT WOULD HAVE CAUSED THE REPORTED EVENT. FURTHER INVESTIGATION REVEALED THAT REPETITIVE USE OF PARAGON CALCAR MILL ON THE PARAGON MALE BROACH HAS CREATED WEAK POINTS ACROSS THE CIRCUMFERENCE OF THE BROACH'S SPIGOT, THUS LEADING TO EVENTUAL BREAKAGE OF THE SPIGOT DURING USE. ADDITIONALLY, A CORRECTIVE AND PREVENTIVE ACTION (CAPA) HAS ALREADY BEEN RAISED AND THE BROACH RE-DESIGN HAS BEEN INITIATED TO ADDRESS THE RISKS ASSOCIATED WITH THE SPIGOT BREAKAGE. BASED ON THIS INVESTIGATION, THE ROOT CAUSE OF THIS EVENT IS PRODUCT DESIGN AND THIS CASE IS NOW CONSIDERED CLOSED. THE MANUFACTURER WILL CONTINUE TO MONITOR EMERGING TRENDS RELATED TO THIS FAILURE MODE. 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

    WE ARE CURRENTLY IN THE PROCESS OF RETRIEVING FURTHER INFORMATION TO PERFORM INVESTIGATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION. 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

    DURING USE, THE BROACH BROKE OFF WHILE BROACHING, MAKE IT UNABLE TO BE EXTRACTED FROM THE FEMORAL CANAL AS USUAL. THE SURGEON HAD TO CARVE AWAY EXTRA BONE TO GET THE BROACH OUT.

    Description of Event or Problem · 0

    DURING USE, THE BROACH BROKE OFF WHILE BROACHING, MAKE IT UNABLE TO BE EXTRACTED FROM THE FEMORAL CANAL AS USUAL. THE SURGEON HAD TO CARVE AWAY EXTRA BONE TO GET THE BROACH OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1556257 PARAGON PARAGON BROACHES SIZE 8 - MALE LZO CORIN LTD GM08001-331-08 J15-185

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown