BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMAL ACCESS ATTACHMENT

    MDR report key: 3964024 · Received December 13, 2013

    Report

    Report Number
    1045834-2013-14160
    Event Type
    Malfunction
    Date Received
    December 13, 2013
    Report Date
    July 21, 2011
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBE
    PMA / PMN Number
    K042783
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 "DOES NOT FUNCTION" COULD NOT BE CONFIRMED. THE DEVICE PASSED ALL TESTS AND NO PROBLEMS WERE OBSERVED. IF ADD'L INFO BECOMES AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED. REF: (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM USA STATING THE DEVICE DID NOT FUNCTION DURING 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
    654356 MINIMAL ACCESS ATTACHMENT HBE DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1