BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANCELLOUS SCREW AXSOS 3 Ø4.0MM / L70MM / FULL THREAD

    MDR report key: 23639410 · Received November 24, 2025

    Report

    Report Number
    0008031020-2025-02102
    Event Type
    Injury
    Date Received
    November 24, 2025
    Date of Event
    June 18, 2025
    Report Date
    November 24, 2025
    Manufacturer
    STRYKER GMBH
    Product Code
    HRS
    UDI-DI
    07613252578673
    PMA / PMN Number
    K222381
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT IS RATED AS CONFIRMED, SINCE THE VISIBLE DAMAGES INDICATE THAT THERE WERE MULTIPLE ISSUE DURING THE SCREW INSERTION. THE DEVICE INSPECTION REVEALED THE FOLLOWING: ONE CANCELLOUS BONE SCREW WAS RETURNED WITHOUT ALLEGATION, BUT DURING THE VISUAL INSPECTION IT WAS DETECTED THAT THE SCREW IS STRONGLY DAMAGED. THE FIRST THREE THREAD FLANKS ARE TOTALLY FLATTENED; THIS INDICATES THAT THERE WAS AN VERY STRONG CONTACT WITH ANOTHER IMPLANT AT THE END OF THE SCREW INSERTION. IN ADDITION, THERE IS A DEEP NOTCH RUNNING ACROSS THE THREAD ON THE SHAFT. THIS NOTCH WAS MOST LIKELY CAUSED BY THE DRILL BIT DURING PRE-DRILLING FOR ANOTHER SCREW. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. BASED ON INVESTIGATION, THE ROOT CAUSE WAS ATTRIBUTED TO A USER RELATED ISSUE. THE EVENT WAS CAUSED BY SELECTING A SCREW TRAJECTORY, WITH A PATH THAT LED TO A COLLISION WITH OTHER IMPLANTS. IF THIS EVENT HAD AN EFFECT ON THE LOCKING SCREWS CAN IN RETROSPECTIVE NOT BE DEFINED. IF MORE INFORMATION IS PROVIDED, THE CASE WILL BE REASSESSED.

    Description of Event or Problem · 0

    AS REPORTED: "A CASE WHERE A PATIENT EXPERIENCED HARDWARE FAILURE AFTER THE INITIAL OPERATION. PLATE HARDWARE LOCKING SCREWS BECAME PROMINENT RESULTING IN HWR SURGERY AND EVENTUALLY A TOTAL KNEE REPLACEMENT ON (B)(6) 2025".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293222 CANCELLOUS SCREW AXSOS 3 Ø4.0MM / L70MM / FULL THREAD PLATE, FIXATION, BONE HRS STRYKER GMBH AE2069 07613252578673

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention