BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMAX 2 PLUS MOTOR

    MDR report key: 3964026 · Received December 13, 2013

    Report

    Report Number
    1045834-2013-14161
    Event Type
    Malfunction
    Date Received
    December 13, 2013
    Report Date
    July 21, 2011
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED BY DEPUY SYNTHES POWER TOOLS. IF ADD'L INFO BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM USA STATING THAT THE DEVICE HAD LOW POWER AND MADE A LOUD RATTLING NOISE DURING KNEE SURGERY. NO INJURY OR MEDICAL INTERVENTION OCCURRED. IT IS UNK IF SURGICAL DELAY OCCURRED. THERE IS NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654419 EMAX 2 PLUS MOTOR HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1