BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATT-HANDPIECE MOD F/TRS

    MDR report key: 3981088 · Received August 5, 2014

    Report

    Report Number
    8030965-2014-00488
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Report Date
    November 20, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    GEY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    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, INSPECTION OF DEVICE REVEALED TRIGGERS JAM. THE TRIGGER PLATE AND GASKETS WERE REPLACED. DEVICE WAS TESTED AND THE ENGINE WAS LEAK PROOF AT OUTPUT. THE DEVICE WAS RETURNED TO CUSTOMER ON (B)(6) 2012. (B)(6). PLACEHOLDER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED DURING OPERATION THE DRILL SWITCH WAS STICKING. THE DRILL WAS CLEANED AND THE SWITCH NO LONGER FUNCTIONED. THIS IS REPORT 1 OF 1 FOR #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456312 BATT-HANDPIECE MOD F/TRS GEY SYNTHES GMBH 5569

    Patients

    Seq Age Sex Outcome Treatment
    1