BEUDAMED
    FDA Adverse Event Other Summary report: N

    RSP INSTRUMENT

    MDR report key: 3331063 · Received August 23, 2013

    Report

    Report Number
    1644408-2013-00455
    Event Type
    Other
    Date Received
    August 23, 2013
    Date of Event
    August 13, 2013
    Report Date
    August 13, 2013
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    HWX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    INSTRUMENT FAILURE - A GUIDE TAP FAILURE OCCURRED DURING THE SURGERY. THE TAP WOULD NOT PENETRATE THE GLENOID. THE SURGEON STATED THAT THE TAP APPEARS TO BE DULL AND NOT FUNCTIONING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411671 RSP INSTRUMENT GUIDE, REAMER, BONE TAP, 6.5MM HWX ENCORE MEDICAL, L.P. 53532L03

    Patients

    Seq Age Sex Outcome Treatment
    1 Other