BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL KEY CHUCK ATTACHMENT W/KEY 1000

    MDR report key: 3973069 · Received April 29, 2014

    Report

    Report Number
    8031000-2014-00232
    Event Type
    Malfunction
    Date Received
    April 29, 2014
    Date of Event
    April 4, 2014
    Report Date
    April 7, 2014
    Manufacturer
    ZIMMER SURGICAL S.A.
    Product Code
    HAB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER AT THE TIME OF THIS REPORT. A FOLLOW UP 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 JACOBS CHUCK OF THE UNIVERSAL KEY CHUCK ATTACHMENT WAS MAKING GRINDING NOISES AND SMALL METAL SHAVINGS APPEARED TO BE PRESENT WITH NO EFFECT TO THE PATIENT BEING REPORTED. NO ADDITIONAL CLINICAL INFORMATION WAS RECEIVED PRIOR TO THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255569 UNIVERSAL KEY CHUCK ATTACHMENT W/KEY 1000 UNIVERSAL KEY CHUCK ATTACHMENT W/ KEY HAB ZIMMER SURGICAL S.A. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1