BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK - POWER

    MDR report key: 4133036 · Received October 1, 2014

    Report

    Report Number
    8030965-2014-01113
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Report Date
    April 11, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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. (B)(6). 510K#: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. DURING PRE-REPAIR ASSESSMENT PERFORMED BY A TECHNICIAN, NO FAILURE OR DEFECT WAS IDENTIFIED. INSPECTION AND MAINTENANCE WERE PERFORMED AND THE DEVICE WAS RETURNED TO THE CUSTOMER ON (B)(6) 2013. PLACEHOLDER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE MOTOR HEATS UP AND THAT ALL THE PARTS NEED TO BE VERIFIED. THIS IS REPORT 1 OF 1 FOR COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612903 UNK - POWER HWE SYNTHES GMBH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1