BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMAL ACCESS ATTACHEMENT

    MDR report key: 3955302 · Received December 13, 2013

    Report

    Report Number
    1045834-2013-14729
    Event Type
    Malfunction
    Date Received
    December 13, 2013
    Date of Event
    July 14, 2011
    Report Date
    July 15, 2011
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBE
    PMA / PMN Number
    K042783
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY DEPUY SYNTHES POWER TOOLS. THE DEVICE WAS EVALUATED AND THE REPORTED CONDITION OF "FROZE WAS NOT CONFIRMED. HOWEVER DURING SERVICE AND REPAIR, DEVICE FAILURES WERE FOUND BTU 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 USA STATING THAT THE DEVICE FROZE. THE DEVICE WAS BEING USED DURING SURGERY. THERE WAS NO PT OR USER INJURY. IT IS UNK IF DELAY OF MEDICAL INTERVENTION OCCURRED. THERE WAS NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654095 MINIMAL ACCESS ATTACHEMENT HBE DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1