BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLIBRI

    MDR report key: 4100928 · Received September 19, 2014

    Report

    Report Number
    8030965-2014-01478
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Report Date
    August 27, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    MOQ
    PMA / PMN Number
    EXEMPT
    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 OUS SERVICE 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 A TECHNICIAN, FUNCTIONAL TESTING WAS PERFORMED AND REVEALED THE MOTOR POWER IS TOO LOW. THE DEVICE WAS REPAIRED AND SENT TO THE CUSTOMER ON (B)(4) 2012. PLACEHOLDER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE DEVICE HAD INTERMITTENT POWER AND SPEED WHICH HINDERED THE SURGEON FROM COMPLETING THE SURGERY. THE SURGEON ALSO HAD TO CHANGE THE DRILL. THIS IS REPORT 1 OF 1 FOR COMPLAINT# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584909 COLIBRI MOQ SYNTHES GMBH 7587

    Patients

    Seq Age Sex Outcome Treatment
    1