BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMAX 2 HAND CONTROL

    MDR report key: 3970034 · Received December 11, 2013

    Report

    Report Number
    1045834-2013-14758
    Event Type
    Malfunction
    Date Received
    December 11, 2013
    Date of Event
    July 8, 2011
    Report Date
    July 8, 2011
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY DEPUY SYNTHES. THE DEVICE WAS EVALUATED AND THE REPORTED CONDITION OF DID NOT FUNCTION COULD NOT BE CONFIRMED. THE DEVICE PASS ALL TESTS AND NO PROBLEMS WERE OBSERVED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED. REF: (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM USA STATING THAT THE DEVICE DID NOT FUNCTION DURING SURGERY. NO INJURY OR MEDICAL INTERVENTION OCCURRED. IT IS UNKNOWN IF SURGICAL DELAY OCCURRED. THERE IS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648309 EMAX 2 HAND CONTROL HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1