BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL AO REAMER ATTACHMENT 250 RPM

    MDR report key: 3130231 · Received May 22, 2013

    Report

    Report Number
    8031000-2013-00050
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 24, 2013
    Manufacturer
    ZIMMER SURGICAL S.A.
    Product Code
    HTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MFR AT THE TIME OF THIS REPORT. A F/U MEDWATCH WILL BE SUBMITTED ONCE THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIVERSAL AO REAMER ATTACHMENT DID NOT WORK. NO ADD'L CLINICAL INFO WAS RECEIVED PRIOR TO THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227165 UNIVERSAL AO REAMER ATTACHMENT 250 RPM UNIVERSAL AO REAMER ATTACHMENT 250 RPM HTO ZIMMER SURGICAL S.A. NA 234465

    Patients

    Seq Age Sex Outcome Treatment
    1