BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLIBRI

    MDR report key: 4131395 · Received October 1, 2014

    Report

    Report Number
    8030965-2014-00865
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Report Date
    April 5, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    MOQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO SYNTHES SERVICE AND REPAIR FILES LEGACY REVIEW/REMEDIATION PROTOCOL-COMPLAINT HANDLING AND MDR REPORTING. 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, INVESTIGATION REVEALED THE MOTOR WAS DEFECTIVE, ROUGH RUNNING, BLOCKED AND SEIZED. THE DEVICE WAS REPAIRED AND RETURNED TO CUSTOMER ON (B)(4) 2013. THE COMPLAINT IS INDETERMINATE. (B)(4). THE 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

    CUSTOMER REPORTED THE DEVICE STOPPED WORKING DURING AN ONGOING SURGERY. THIS IS REPORT 1 OF 1 FOR #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611999 COLIBRI MOQ SYNTHES GMBH 11310

    Patients

    Seq Age Sex Outcome Treatment
    1