BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO SOLUTIONS ANKLE FRACTURE PLATING SYSTEM

    MDR report key: 22749319 · Received August 8, 2025

    Report

    Report Number
    3008951116-2025-00002
    Event Type
    Malfunction
    Date Received
    August 8, 2025
    Date of Event
    July 5, 2025
    Report Date
    August 8, 2025
    Manufacturer
    ORTHO SOLUTIONS UK LTD
    Product Code
    HXX
    UDI-DI
    05055662962833
    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

    A RECALL WAS INITIATED OF 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). ONLY TWO FURTHER DEVICES OF THIS LOT WERE IN THE FIELD, BOTH IN THE UK. THIS RECALL HAS NOW BEEN COMPLETED SUCCESSFULLY. AS THE RECALL ONLY AFFECTED THIS ONE BATCH, NONE OF WHICH HAVE BEEN SOLD OR DISTRIBUTED IN THE USA, NO FIELD SAFETY CORRECTIVE ACTIONS ARE APPLICABLE TO THE USA FOR THIS ISSUE. AN ADDITIONAL REPORT WILL BE SUBMITTED FOR THE SCREW WHICH FRACTURED IN THE SAME EVENT.

    Description of Event or Problem · 0

    THE TIP OF THE SCREWDRIVER SHANK WAS REPORTED TO HAVE FRACTURED INTRAOPERATIVELY ALONG WITH A SCREW. THIS CAUSED A MINOR DELAY TO SURGERY TO REMOVE THE FRACTURED SCREW INCLUDING AN ADDITIONAL INCISION. ANOTHER SCREWDRIVER SHANK OF THE SAME PRODUCT CODE AND LOT NUMBER WAS REPORTED TO HAVE DEFORMED AT THE TIP DURING USE. 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
    1903938 ORTHO SOLUTIONS ANKLE FRACTURE PLATING SYSTEM T10 SCREWDRIVER BIT, SELF-RETAINING HXX ORTHO SOLUTIONS UK LTD OS721010-NS 915999 05055662962833

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other