BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATT-HANDPIECE MOD F/TRS

    MDR report key: 4111344 · Received September 23, 2014

    Report

    Report Number
    8030965-2014-01312
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Report Date
    September 26, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    GEY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. 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, IT WAS NOTICED THAT THE DEVICE HAD NOT BEEN SERVICED AND THERE WERE SIGNS OF NORMAL WEAR. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER ON (B)(4) 2012. PLACEHOLDER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE TRAUMA RECON SYSTEM COULD NOT BE SWITCHED OFF INTRA-OPERATIVELY. THIS IS REPORT 1 OF 1 FOR EVENT# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590351 BATT-HANDPIECE MOD F/TRS GEY SYNTHES GMBH 2929

    Patients

    Seq Age Sex Outcome Treatment
    1