BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATT-HANDPIECE MOD F/TRS

    MDR report key: 4102081 · Received September 19, 2014

    Report

    Report Number
    8030965-2014-01178
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Report Date
    February 4, 2013
    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. (B)(6). DURING PRE-REPAIR ASSESSMENT PERFORMED BY A TECHNICIAN, IT WAS REVEALED THAT THE TRIGGER WAS JAMMED. THIS WAS ATTRIBUTED TO NORMAL WEAR. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER ON (B)(6) 2013. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE WAS RETURNED FOR REPAIR. DURING SERVICE, TECHNICIAN REPLACED SEVERAL PARTS DUE TO A JAMMED TRIGGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582289 BATT-HANDPIECE MOD F/TRS GEY SYNTHES GMBH 3582

    Patients

    Seq Age Sex Outcome Treatment
    1