BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATT-HANDPIECE MOD F/TRS

    MDR report key: 3941356 · Received July 17, 2014

    Report

    Report Number
    8030965-2014-00479
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Report Date
    August 30, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    GEY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    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 REVEALED THE TRIGGER, SLIDER WAS BLOCKED OR JAMMED DUE TO AN ASSEMBLY ERROR. SPRING WAS POSITIONED INCORRECTLY DURING PRODUCTION. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER (B)(4) 2012. PLACEHOLDER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE SPRING IN THE UPPER REVERSE BUTTON DOES NOT FUNCTION. THIS IS REPORT 1 OF 1 FOR #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418595 BATT-HANDPIECE MOD F/TRS GEY SYNTHES GMBH 5750

    Patients

    Seq Age Sex Outcome Treatment
    1