BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATT-HANDPIECE MOD F/TRS

    MDR report key: 4091315 · Received September 16, 2014

    Report

    Report Number
    8030965-2014-01043
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Report Date
    October 4, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    GEY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO SYNTHES 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. (B)(6). DURING PRE-REPAIR ASSESSMENT PERFORMED BY A TECHNICIAN, IT WAS REVEALED THAT THE TRIGGER WAS BROKEN AND THE DEVICE WAS IN NEED OF SERVICE. THIS WAS ATTRIBUTED TO NORMAL WEAR AND FAULTY HANDLING. MAINTENANCE WAS PERFORMED AND THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER ON (B)(4) 2012. PLACEHOLDER.

    Description of Event or Problem · 1

    CUSTOMER SENT THE DEVICE IN FOR SERVICE/REPAIR. TECHNICIAN FOUND THAT THE TRIGGER, SLIDER WAS BROKEN. THIS IS REPORT 1 OF 1 FOR COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573498 BATT-HANDPIECE MOD F/TRS GEY SYNTHES GMBH 2053

    Patients

    Seq Age Sex Outcome Treatment
    1