BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIBLE SHAFT W/CIR CONNECTOR

    MDR report key: 6055766 · Received October 25, 2016

    Report

    Report Number
    1020279-2016-00825
    Event Type
    Malfunction
    Date Received
    October 25, 2016
    Date of Event
    October 15, 2016
    Report Date
    October 15, 2016
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    MDM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MDR 1020279-2016-00825 WAS SUBMITTED IN ERROR. PLEASE DISREGARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THE FLEXIBLE REAMER SHAFT BROKE WHILE USING THE FINAL REAMER DURING TIBIAL METANAIL PROCEDURE. PROPER REAMING OF THE DIAPHYSIS WAS OBTAINED. NO BROKEN PIECES OF THE SHAFT WAS LEFT IN PATIENT. NO DELAY IN PROCEDURE. NO INJURY OCCURRED FROM INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706748 FLEXIBLE SHAFT W/CIR CONNECTOR TRAUMA INSTRUMENT MDM SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization