BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPTURED CORTICAL SCREW, Ø5.0MM X 36MM

    MDR report key: 22282287 · Received June 18, 2025

    Report

    Report Number
    1220246-2025-02504
    Event Type
    Injury
    Date Received
    June 18, 2025
    Date of Event
    November 25, 2024
    Report Date
    June 18, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    HSB
    UDI-DI
    00848665019131
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT ALLEGATION IS CONFIRMED. VISUAL INSPECTION, IT WAS NOTED THAT THREADS OF THE CAPTURED CORTICAL SCREW, Ø5.0MM X 36MM WERE DAMAGED. FUNCTIONAL TESTING WAS PERFORMED AND NOTED THAT THE SCREW DID NOT WORK AS REQUIRED DUE TO THE DAMAGED OF THE THREADS. PER SURGICAL TECHNIQUE NAIL SYSTEM: THE ES HOLE IS EASILY TARGETED THROUGH THE NAIL JIG WITHOUT THE NEED FOR PERFECT CIRCLES OR ADDITIONAL ATTACHMENTS OR DEVICES. PREOPERATIVE PLANNING PREOPERATIVE RADIOGRAPHS OF THE UNINJURED FEMUR MAY BE USED TO ESTABLISH PROPER NAIL DIAMETER, EXPECTED AMOUNT OF REAMING (IF NECESSARY), LAG SCREW ANGLE, NAIL LENGTH, AND LAG SCREW LENGTH. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR OF THE DEVICE DUE TO MISALIGNED INSERTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN INTERTROCHANTERIC FRACTURE SURGERY THE LAG SCREW AND ANTI-ROTATION SCREW BACKED OUT OF THE NAIL AND THE NAIL LAGSCREW HOLE LOOKED DAMAGED. IT WAS FURTHER REPORTED THAT THE PATIENT WENT IN FOR A TOTAL HIP REPLACEMENT ON THE (B)(6) 2024. UPDATE DW 21-MAY-2025 DURING THE EVALUATION IT WAS FOUND THAT IN ADDITION A 8001-036 WAS RETURNED AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864185 CAPTURED CORTICAL SCREW, Ø5.0MM X 36MM INTRAMED FIXATN ROD AND ACCESS HSB ARTHREX, INC. CAPTURED CORTICAL SCREW, Ø5.0MM X 36MM 00848665019131

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other