BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLIBRI II

    MDR report key: 3950315 · Received July 22, 2014

    Report

    Report Number
    8030965-2014-00485
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Report Date
    January 25, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    MOQ
    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 SYNTHES (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. DURING PRE-REPAIR ASSESSMENT PERFORMED BY TECHNICIAN, FUNCTIONAL TESTING REVEALED THE COUPLING HEAD JAMS AND THE MOTOR ROUGH RUNNING, INTERMITTENT AND SEIZED DUE TO COMPONENTS. THE COUPLING LATCHES AND MOTOR WERE REPAIRED, TESTED AND RETURNED TO CUSTOMER ON 2/5/2013. 510K: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. PLACEHOLDER.

    Description of Event or Problem · 1

    DURING SERVICE, TECHNICIAN FOUND THE MOTOR JERKS AND THE COUPLING HEAD JAMS. THIS IS REPORT 1 OF 1 FOR #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429128 COLIBRI II MOQ SYNTHES GMBH 1203

    Patients

    Seq Age Sex Outcome Treatment
    1