BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIR OSCILLATOR

    MDR report key: 4153441 · Received October 8, 2014

    Report

    Report Number
    8030965-2014-01316
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Report Date
    May 29, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    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 TECHNICIAN, IT WAS NOTED THAT THE COUPLING DOES NOT FUNCTION PROPERLY DO TO NORMAL WEAR. MAINTENANCE WAS PERFORMED AND THE DEVICE WAS RETURNED TO THE CUSTOMER ON (B)(4) 2013. PLACEHOLDER.

    Description of Event or Problem · 1

    THE CUSTOMER RETURNED THE DEVICE REPORTING THE SAW BLADE CAME OFF DURING SURGERY. THIS IS REPORT 1 OF 1 FOR EVENT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631061 AIR OSCILLATOR HWE SYNTHES GMBH 2151

    Patients

    Seq Age Sex Outcome Treatment
    1