BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T-FIX RCG STERILE PAC

    MDR report key: 5539776 · Received March 31, 2016

    Report

    Report Number
    1219602-2016-00174
    Event Type
    Injury
    Date Received
    March 31, 2016
    Date of Event
    February 23, 2016
    Report Date
    March 18, 2016
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HRX
    PMA / PMN Number
    K925573
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE INVESTIGATION NARRATIVE - EXAMINATION WAS NOT POSSIBLE, AS THE DEVICE WILL NOT BE RETURNED. THE INVESTIGATION WAS LIMITED TO THE INFORMATION PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT WITHOUT THE RETURN OF THE DEVICE. NO FURTHER INVESTIGATION IS WARRANTED AT THIS TIME. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    IT IS REPORTED THAT AFTER AN ARTHROSCOPIC PROCEDURE THE SURGEON X-RAYED THE PATIENT AND SAW THAT A PART OF THE GLENOID DRILL HAD BROKEN OFF AND BEEN LEFT IN THE GLENOID. PATIENT WAS MADE AWARE OF THIS AND NO FURTHER ACTION HAS BEEN TAKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195963 T-FIX RCG STERILE PAC ARTHROSCOPE HRX SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention