BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-FIX RCG DISPOSABLE

    MDR report key: 1748593 · Received July 7, 2010

    Report

    Report Number
    1219602-2010-00180
    Event Type
    Malfunction
    Date Received
    July 7, 2010
    Date of Event
    May 14, 2010
    Report Date
    May 14, 2010
    Manufacturer
    SMITH & NEPHEW ENDOSCOPY
    Product Code
    HRX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4): DEVICE IS NOT BEING RETURNED FOR EVALUATION.(B) (4)

    Description of Event or Problem · 1

    CUSTOMER THINKS THE DEPTH GAUGE IS MISLEADING AND DOES NOT PUT THE IMPLANT ALL THE WAY THROUGH TISSUE FOR GOOD FIXATION. DISCOVERED UPON FOLLOW-UP EXAM WITH PATIENT. IT WAS STATED THAT THIS PATIENT PRESENTED TO THE SURGEON WITH PAIN AND RANGE OF MOTION ISSUES. POST-OP DURATION UNKNOWN. X-RAYS WERE TAKEN REVEALING INADEQUATE FIXATION. ANCHORS WERE THEN REMOVED AND REPLACED WITH AN UNKNOWN FIXATION DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 T-FIX RCG DISPOSABLE T-FIX RCG STERILE PAC HRX SMITH & NEPHEW ENDOSCOPY 014771 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention