BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AEQUALIS REVERSED HEXAGONAL DRIVER TIP

    MDR report key: 4780586 · Received May 15, 2015

    Report

    Report Number
    9610667-2015-00100
    Event Type
    Malfunction
    Date Received
    May 15, 2015
    Date of Event
    April 28, 2015
    Report Date
    April 28, 2015
    Manufacturer
    TORNIER SAS
    Product Code
    KWS
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE INITIAL REPORT SUBMITTED REGARDING THIS SURGICAL EVENT AND MEDICAL DEVICE.

    Description of Event or Problem · 1

    DRIBER TIP BROKE UPON SCREWING IN THE GLENOSPHERE, THE FRAGMENT REMAINED IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319352 AEQUALIS REVERSED HEXAGONAL DRIVER TIP NI KWS TORNIER SAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other