BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    R3 STRAIGHT SHELL IMPACTOR

    MDR report key: 6284046 · Received January 27, 2017

    Report

    Report Number
    1020279-2017-00067
    Event Type
    Malfunction
    Date Received
    January 27, 2017
    Date of Event
    January 17, 2017
    Report Date
    January 17, 2017
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    MDM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PLEASE DISREGARD MDR 1020279-2017-00067 AS IT WAS SUBMITTED IN ERROR.

    Description of Event or Problem · 1

    IT WAS REPORTED THE METAL PIECE ON IMPACTOR BROKE. THE WELD IS BROKEN. THE DEVICE MALFUNCTIONED AND PER CASE BASIS IT WAS DEEMED THAT THIS MALFUNCTION CAN LEAD TO A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65542 R3 STRAIGHT SHELL IMPACTOR HIP INSTRUMENT MDM SMITH & NEPHEW, INC. 14LSA0001

    Patients

    Seq Age Sex Outcome Treatment
    1 Other