BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROMAX MOTOR ASSY

    MDR report key: 4183255 · Received October 17, 2014

    Report

    Report Number
    1045834-2014-13916
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Report Date
    April 4, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    ERL
    PMA / PMN Number
    PK965080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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). THE DEVICE WAS RECEIVED FOR EVALUATION. DURING PRE-REPAIR ASSESSMENT, INVESTIGATION REVEALED THE DEVICE RPM WAS BELOW SPECIFICATION. THE DEVICE WAS REPAIRED AND RETURNED TO CUSTOMER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE DEVICE WOULD NOT FUNCTION AND REQUESTED ROUTINE MAINTENANCE. THIS IS REPORT 1 OF 1 FOR #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661041 MICROMAX MOTOR ASSY EAR, NOSE, AND THROAT ELECTRIC OR PNEUMATIC SURGICAL DRILL ERL DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1