BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETROGRADE DRL 9.5MM

    MDR report key: 6402334 · Received March 14, 2017

    Report

    Report Number
    1219602-2017-00293
    Event Type
    Malfunction
    Date Received
    March 14, 2017
    Date of Event
    February 16, 2017
    Report Date
    April 27, 2017
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GFG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE INVESTIGATION NARRATIVE - TWO 9.5MM RETROGRADE DRILLS WERE RETURNED FOR EVALUATION. VISUAL ASSESSMENT OF SAMPLE (A) SHOWED THE ACTUATOR IS DRAMATICALLY BENT NOT ALLOWING THE CUTTER HEAD TO ADVANCE OUT OF THE DRILL SHAFT. VISUAL ASSESSMENT OF SAMPLE (B) SHOWED THE ACTUATOR HAS COME UNCOILED CAUSING IT TO DISENGAGE FROM THE CUTTER HEAD PROHIBITING THE DRILL TO ADVANCE IN ANY DIRECTION. A ROOT CAUSE INVESTIGATION HAS BEEN OPENED TO ADDRESS THIS FAILURE MODE. DEVICE EVALUATED BY THE MANUFACTURER (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD A BROKEN HINGE PIN AND WOULD NOT FUNCTION CORRECTLY. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITHOUT INCIDENT OR PATIENT IMPACT FOLLOWING A SHORT DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184959 RETROGRADE DRL 9.5MM BIT, SURGICAL GFG SMITH & NEPHEW, INC. F93300

    Patients

    Seq Age Sex Outcome Treatment
    1