BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EQUINOXE SHOULDER REVERSE INSTRUMENT CASE

    MDR report key: 3841187 · Received February 27, 2014

    Report

    Report Number
    1038671-2014-00068
    Event Type
    Malfunction
    Date Received
    February 27, 2014
    Date of Event
    January 13, 2014
    Report Date
    February 28, 2014
    Manufacturer
    EXACTECH INC.
    Product Code
    KWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONTRIBUTION OF THE DEVICES TO THE EXPERIENCE REPORTED COULD NOT BE DETERMINED AS THE DEVICES WERE NOT RETURNED FOR EVAL.

    Description of Event or Problem · 1

    A PT HAD BEEN ADMINISTERED ANALGESIA AND HAD TO BE WOKEN DUE TO A HOLE IN THE PAPER WRAPPING OF THE INSTRUMENT TRAYS. SURGERY WENT AHEAD AS PLANNED LATER IN THE DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121630 EQUINOXE SHOULDER REVERSE INSTRUMENT CASE INSTRUMENT CASE KWS EXACTECH INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization