BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPUY DELTA EXTEND

    MDR report key: 2328008 · Received November 4, 2011

    Report

    Report Number
    MW5022975
    Event Type
    Malfunction
    Date Received
    November 4, 2011
    Date of Event
    August 11, 2011
    Report Date
    November 4, 2011
    Manufacturer
    DEPUY ORTHOPEDICS
    Product Code
    KWS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING REVERSE SHOULDER ARTHROSCOPY, THE ECCENTRIC GLENOSPHERE GUIDE WAS BEING TIGHTENED AND DURING THE PROCESS THE KEYED TIP BROKE OFF (LESS THAN 2MM X 1MM). THE SURGEON WAS UNABLE TO LOCATE AND RETRIEVE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY DELTA EXTEND GLENOSPHERE ORIENTATION GUIDE KWS DEPUY ORTHOPEDICS

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR