BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLIBRI

    MDR report key: 4124052 · Received September 27, 2014

    Report

    Report Number
    8030965-2014-00682
    Event Type
    Malfunction
    Date Received
    September 27, 2014
    Report Date
    February 6, 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 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, INSPECTION REVEALED THE MOTOR CONSUMED TOO MUCH CURRENT AND WAS ROUGH RUNNING. THE LOCKING MECHANISM OF THE BATTERY WAS JAMMED. SEVERAL PARTS WERE REPLACED TO REPAIR AND THE DEVICE WAS RETURNED TO THE CUSTOMER ON (B)(4) 2013. THIS COMPLAINT IS INDETERMINATE. (B)(6). 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 GOT HOT, OVERHEATED DURING DRILLING. THIS IS REPORT 1 OF 1 FOR # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603455 COLIBRI MOQ SYNTHES GMBH 1487

    Patients

    Seq Age Sex Outcome Treatment
    1