BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11.0 CM LONG ATTACHMENT

    MDR report key: 3960011 · Received December 13, 2013

    Report

    Report Number
    1045834-2013-14634
    Event Type
    Malfunction
    Date Received
    December 13, 2013
    Date of Event
    December 8, 2011
    Report Date
    December 8, 2011
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY DEPUY SYNTHES POWER TOOLS. THE INVESTIGATION IS STILL IN PROCESS. WHEN THE INVESTIGATION HAS BEEN COMPLETED OR 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 CUTTER COULD NOT BE REMOVED FROM THE DEVICE. THE DEVICE WAS BEING USED DURING SURGERY. THERE WAS NO INJURY REPORTED. 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
    654414 11.0 CM LONG ATTACHMENT HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1