BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROMAX-PLUS LP MOTOR ASSY

    MDR report key: 3955422 · Received December 13, 2013

    Report

    Report Number
    1045834-2013-13912
    Event Type
    Malfunction
    Date Received
    December 13, 2013
    Date of Event
    April 6, 2011
    Report Date
    April 11, 2011
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    ERL
    PMA / PMN Number
    K965080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY DEPUY SYNTHES POWER TOOLS. THE DEVICE WAS EVALUATED AND THE REPORTED CONDITION OF AIR LEAK COULD NOT BE CONFIRMED. HOWEVER DURING SERVICE AND REPAIR, DEVICE FAILURES WERE FOUND BUT WERE NOT RELATED TO THE REPORTED EVENT. IF ADD'L INFO IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    REPORT RECEIVED FROM (B)(6) STATING THAT THE DEVICE HAD AN AIR LEAK. THE DEVICE WAS USED IN SURGERY. THERE WAS NO PT OR USER INJURY. IT IS UNK IF MEDICAL INTERVENTION OCCURRED. THERE WAS NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654120 MICROMAX-PLUS LP MOTOR ASSY ERL DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1