BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2013-03390

    MDR report key: 3171641 · Received June 15, 2013

    Report

    Report Number
    2520274-2013-03390
    Event Type
    Malfunction
    Date Received
    June 15, 2013
    Date of Event
    February 23, 2012
    Report Date
    February 27, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    MOQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. 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). WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A PROCEDURE ON (B)(6) 2012, THE HAND PIECE IS OVER-HEATING AND IS MAKING A LOUD NOISE WHEN IN USE. THE DEVICE HAS BEEN CHECKED AND SERVICED BY THE HOSPITAL'S BIOMEDICAL ENGINEERING DEPARTMENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272472 MOQ SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1