BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATT-HANDPIECE MOD F/TRS

    MDR report key: 3941359 · Received July 17, 2014

    Report

    Report Number
    8030965-2014-00463
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Report Date
    January 17, 2013
    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 (B)(6) AND REPAIR FILES LEGACY REVIEW/REMEDIATION PROTOCOL-COMPLAINT HANDLING AND MDR REPORTING. 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 TECHNICIAN, FUNCTIONAL TESTING IDENTIFIED NO FAILURES FOR DEVICE. THE DEVICE WAS TESTED EXTENSIVELY BEFORE BEING RETURNED TO CUSTOMER ON (B)(6) 2013. PLACEHOLDER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED DEVICE OVERHEATED AND BATTERY DID NOT HAVE SUFFICIENT CHARGE TO COMPLETE ONE SURGERY. THIS IS REPORT 1 OF 1 FOR #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418596 BATT-HANDPIECE MOD F/TRS GEY SYNTHES GMBH 6121

    Patients

    Seq Age Sex Outcome Treatment
    1