BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPD 60000 RPM

    MDR report key: 4113848 · Received September 24, 2014

    Report

    Report Number
    8030965-2014-00748
    Event Type
    Malfunction
    Date Received
    September 24, 2014
    Report Date
    March 26, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    K043310
    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. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. 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 A TECHNICIAN, FUNCTIONAL TESTING WAS PERFORMED AND REVEALED THE MOTOR DOES NOT FUNCTION PROPERLY AND THE PIN IS BENT. THIS WAS ATTRIBUTED 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 REPORTED THAT THE FRAISE GETS HEATED VERY FAST. THIS IS REPORT 1 OF 1 FOR COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595032 EPD 60000 RPM HWE SYNTHES GMBH 2293

    Patients

    Seq Age Sex Outcome Treatment
    1