BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T2 ALPHA FEMUR RETROGRADE - DTD FEMUR RETROGRADE

    MDR report key: 23632949 · Received November 24, 2025

    Report

    Report Number
    0008031020-2025-02095
    Event Type
    Malfunction
    Date Received
    November 24, 2025
    Date of Event
    October 23, 2025
    Report Date
    December 17, 2025
    Manufacturer
    STRYKER GMBH
    Product Code
    HSB
    UDI-DI
    07613327411843
    PMA / PMN Number
    K250163
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCES WERE PROVIDED. A REVIEW OF THE DEVICE HISTORY WAS NOT POSSIBLE BECAUSE THE LOT NUMBER WAS NOT COMMUNICATED. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. INDICATIONS OF MATERIAL, MANUFACTURING, OR DESIGN RELATED PROBLEMS WERE UNABLE TO BE IDENTIFIED AS THE LOT NUMBER WAS NOT COMMUNICATED. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. IF THE DEVICE IS RETURNED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    AS REPORTED: "WHEN INSERTING THE DISTAL ADVANCE LOCKING SCREW, THE DISTAL TARGETING DEVICE WAS LOOSE, AND THE SCREW WAS DRIVEN IN AT AN INCORRECT ANGLE BEYOND THE ACCEPTABLE INSERTION RANGE. AS A RESULT, THE SCREW BECAME STUCK WITH THE NAIL AND COULD NOT BE REMOVED. ALTHOUGH IT WAS EVENTUALLY EXTRACTED WITH EFFORT, THE PRODUCTS WERE DAMAGED." 11/06/2025 - ADDITIONAL INFORMATION RECEIVED: HOW WAS THE ISSUE SOLVED? LONGER SCREW DRIVER WAS USED AS AN ALTERNATIVE.

    Description of Event or Problem · 0

    AS REPORTED: "WHEN INSERTING THE DISTAL ADVANCE LOCKING SCREW, THE DISTAL TARGETING DEVICE WAS LOOSE, AND THE SCREW WAS DRIVEN IN AT AN INCORRECT ANGLE BEYOND THE ACCEPTABLE INSERTION RANGE. AS A RESULT, THE SCREW BECAME STUCK WITH THE NAIL AND COULD NOT BE REMOVED. ALTHOUGH IT WAS EVENTUALLY EXTRACTED WITH EFFORT, THE PRODUCTS WERE DAMAGED." 11/06/2025 - ADDITIONAL INFORMATION RECEIVED: HOW WAS THE ISSUE SOLVED? LONGER SCREW DRIVER WAS USED AS AN ALTERNATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566609 T2 ALPHA FEMUR RETROGRADE - DTD FEMUR RETROGRADE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER GMBH UNKNOWN 07613327411843

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male