BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL KEYLESS DRILL ATTACHMENT 1000 RPM

    MDR report key: 2971239 · Received February 1, 2013

    Report

    Report Number
    8031000-2013-00001
    Event Type
    Malfunction
    Date Received
    February 1, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 4, 2013
    Manufacturer
    ZIMMER SURGICAL S.A.
    Product Code
    GFA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    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 KEYLESS DRILL ATTACHMENT HAD A BAD FIXATION OF INSTRUMENTS. IT LOOSENS ALL THE TIME. NO ADD'L CLINICAL INFO WAS RECEIVED PRIOR TO THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45377 UNIVERSAL KEYLESS DRILL ATTACHMENT 1000 RPM UNIVERSAL KEYLESS DRILL ATTACHMENT 1000 GFA ZIMMER SURGICAL S.A. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1