BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATT-HANDPIECE MOD F/TRS

    MDR report key: 3920149 · Received July 8, 2014

    Report

    Report Number
    8030965-2014-00448
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Report Date
    September 27, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    GEY
    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. (B)(6). DURING PRE-REPAIR ASSESSMENT PERFORMED BY TECHNICIAN, NO FAILURE WAS IDENTIFIED IN THE FUNCTIONAL TESTING. THE UNIT WAS SERVICED AND RETURNED TO THE CUSTOMER ON (B)(6) 2012. PLACEHOLDER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE BATTERY HANDPIECE, MODULAR, FOR TRAUMA RECON SYSTEM OVERHEATS. THIS IS REPORT 1 OF 1 FOR EVENT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397140 BATT-HANDPIECE MOD F/TRS GEY SYNTHES GMBH 5668

    Patients

    Seq Age Sex Outcome Treatment
    1