BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLIBRI

    MDR report key: 3962672 · Received July 29, 2014

    Report

    Report Number
    8030965-2014-00436
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Report Date
    September 20, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT NOT DIAGNOSIS. SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO (B)(4) AND REPAIR FILES LEGACY REVIEW/REMEDIATION PROTOCOL-COMPLAINT HANDLING AND MDR REPORTING. DEVICE(S) LISTED IN THIS REPORT IS (ARE) 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 SERVICE, TECHNICIAN FOUND THAT THE MOTOR HAD AN INTERRUPTION IN THE WINDING. THE MOTOR DOES NOT ROTATE VERY WELL AND IT GETS HOT. THE MOTOR WAS REPLACED. DEVICE REPAIRED AND RETURNED TO THE CUSTOMER ON (B)(4) 2012. PLACEHOLDER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE MOTOR DID NOT ROTATE VERY WELL AND GOT HOT. THIS IS 1 OF 1 REPORT FOR EVENT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441275 COLIBRI HWE SYNTHES GMBH 5563

    Patients

    Seq Age Sex Outcome Treatment
    1