BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MDA ASSEMBLY

    MDR report key: 3960012 · Received December 13, 2013

    Report

    Report Number
    1045834-2013-13504
    Event Type
    Malfunction
    Date Received
    December 13, 2013
    Date of Event
    October 25, 2011
    Report Date
    October 25, 2011
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    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 BURR IS STUCK IN ATTACHMENT 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. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM USA INDICATING THE "BURR IS STUCK IN ATTACHMENT". IT IS KNOWN THAT THE DEVICE WAS USED IN SURGERY AND THAT NO INJURY WAS REPORTED. IT IS NOT KNOWN IF MEDICAL INTERVENTION OCCURRED. THERE WAS NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654289 MDA ASSEMBLY HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1