BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO SOLUTIONS ANKLE FRACTURE PLATING SYSTEM

    MDR report key: 22749596 · Received August 8, 2025

    Report

    Report Number
    3008951116-2025-00003
    Event Type
    Malfunction
    Date Received
    August 8, 2025
    Date of Event
    August 5, 2025
    Report Date
    August 8, 2025
    Manufacturer
    ORTHO SOLUTIONS UK LTD
    Product Code
    HWC
    PMA / PMN Number
    K202764
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AN ADDITIONAL REPORT WILL BE SUBMITTED FOR THE DRIVER WHICH FRACTURED IN THE SAME EVENT. A RECALL WAS INITIATED OF THE DRIVER, OS721010-NS LOT 915999 (MANUFACTURER REFERENCE: CAPA 003-25), DUE TO THE POTENTIAL LINK IDENTIFIED BETWEEN ITS DIMENSIONAL NONCONFORMANCE AND THE EVENT REPORTED IN (B)(6). NO UDI INFORMATION ON THE SCREW IS CURRENTLY AVAILABLE.

    Description of Event or Problem · 0

    A SCREW WAS REPORTED TO HAVE FRACTURED INTRAOPERATIVELY ALONG WITH THE TIP OF A SCREWDRIVER SHANK. THIS CAUSED A MINOR DELAY TO SURGERY TO REMOVE THE FRACTURED SCREW INCLUDING AN ADDITIONAL INCISION. IT WAS CONFIRMED THAT THE SURGERY WAS ULTIMATELY COMPLETED SUCCESSFULLY WITH NO FURTHER IMPACT ON THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2065772 ORTHO SOLUTIONS ANKLE FRACTURE PLATING SYSTEM UNKNOWN HWC ORTHO SOLUTIONS UK LTD UNKNOWN - VOLITION SCREW UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other