BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DTD FEMUR RETROGRADE T2 ALPHA FEMUR RETROGRADE

    MDR report key: 19710015 · Received July 10, 2024

    Report

    Report Number
    0009610622-2024-00458
    Event Type
    Injury
    Date Received
    July 10, 2024
    Date of Event
    June 13, 2024
    Report Date
    September 30, 2024
    Manufacturer
    STRYKER GMBH
    Product Code
    HSB
    UDI-DI
    07613327411843
    PMA / PMN Number
    K203819
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    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 EVIDENCE WAS PROVIDED. VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTION WAS NOT POSSIBLE DUE TO MISSING ITEM. 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. LABELLING REQUIRES LUBRICATION OF ALL MOVABLE PARTS AFTER RE-PROCESSING. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. IN THE CASE PRESENTED A PATIENT SHOULD BE TREATED USING ABOVE TARGET DEVICE WHICH WOULD NOT ATTACH TO NAIL HOLDING JIG UNLESS GREAT FORCE WAS APPLIED. ONCE ATTACHED, WITH GREAT EFFORT, IT COULD NOT BE REMOVED. THOSE ATTEMPTS HAD CAUSED DELAY OF APPROX. 30 MINUTES WHICH IS WITHIN ESTIMATED RISK ASSESSMENT. WITH AVAILABLE INFORMATION A REAL ROOT CAUSE COULD NOT BE DETERMINED. IT COULD NOT BE FIGURED OUT IF LUBRICATION WAS MISSING AFTER RE-PROCESSING. IN CASE OF A MANUFACTURING ISSUE THE EVENT WOULD BE COVERED BY ALREADY FILED NC. WITH AVAILABLE INFORMATION A PRODUCT DEFICIENCY WAS NOT VERIFIED.

    Additional Manufacturer Narrative · 0

    BASED ON THE AVAILABLE INFORMATION THE DEVICE WILL NOT BE RETURNED THEREFORE AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    AS REPORTED: "T2 ALPHA FEMUR RETROGRADE DISTAL TARGETING ATTACHMENT MALFUNCTIONED AND WOULD NOT ATTACH TO NAIL HOLDING JIG UNLESS GREAT FORCE WAS APPLIED. ONCE ATTACHED, WITH GREAT EFFORT, IT COULD NOT BE REMOVED. COULD NOT UTILIZE PROXIMAL TARGETING ATTACHMENT, ALSO HAD TO ACQUIRE VARIOUS ADDITIONAL X-RAY ANGLES TO PROPERLY ASCERTAIN NAIL PLACEMENT, SINCE WE COULD NOT REMOVE DISTAL TARGETING ATTACHMENT. BOTH OF THESE CAUSED A PROLONGED PROCEDURE OF 30 MIN."

    Description of Event or Problem · 0

    AS REPORTED: "T2 ALPHA FEMUR RETROGRADE DISTAL TARGETING ATTACHMENT MALFUNCTIONED AND WOULD NOT ATTACH TO NAIL HOLDING JIG UNLESS GREAT FORCE WAS APPLIED. ONCE ATTACHED - WITH GREAT EFFORT - IT COULD NOT BE REMOVED. COULD NOT UTILIZE PROXIMAL TARGETING ATTACHMENT, ALSO HAD TO ACQUIRE VARIOUS ADDITIONAL X-RAY ANGLES TO PROPERLY ASCERTAIN NAIL PLACEMENT, SINCE WE COULD NOT REMOVE DISTAL TARGETING ATTACHMENT. BOTH OF THESE CAUSED A PROLONGED PROCEDURE OF 30 MIN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447517 DTD FEMUR RETROGRADE T2 ALPHA FEMUR RETROGRADE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER GMBH KP476521 07613327411843

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention