BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLIBRI

    MDR report key: 3955769 · Received July 24, 2014

    Report

    Report Number
    8030965-2014-00490
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Report Date
    March 14, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    EKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO (B)(4) AND REPAIR FILES LEGACY REVIEW/REMEDIATION PROTOCOL-COMPLAINT HANDLING AND MDR REPORTING. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. 510K#: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. DURING PRE-REPAIR ASSESSMENT PERFORMED BY TECHNICIAN THE MOTOR SEIZED, JAMMED, AND OVERHEATED. THE EVALUATION FOUND THIS FAILURE WAS DUE TO NORMAL WEAR. THE UNIT WAS SERVICED AND SEVERAL COMPONENTS WERE REPLACED. THE UNIT WAS REPAIRED AND RETURNED TO THE CUSTOMER ON 3/27/2013. PLACEHOLDER.

    Description of Event or Problem · 1

    THE CUSTOMER CLAIMED THE MOTOR WAS DEFECTIVE. THIS IS REPORT 1 OF 1 FOR EVENT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434239 COLIBRI EKX SYNTHES GMBH 10040

    Patients

    Seq Age Sex Outcome Treatment
    1