BEUDAMED
    FDA Adverse Event Summary report: N

    11.0 CM LONG ATTACHMENT

    MDR report key: 3832265 · Received August 14, 2013

    Report

    Report Number
    1045834-2013-03991
    Date Received
    August 14, 2013
    Date of Event
    December 27, 2011
    Report Date
    January 12, 2012
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN REC'D BY DEPUY SYNTHES POWER TOOLS. THE INVESTIGATION IS STILL IN PROCESS. WHEN THE INVESTIGATION HAS BEEN COMPLETED OR ADD'L INFO BECOMES, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT REC'D FROM USA STATING THAT THE DEVICE CAN NOT SECURE CUTTER. THE DEVICE WAS NOT BEING USED DURING SURGERY. IT IS UNK IF INJURY OR MEDICAL INTERVENTION OCCURRED. THERE WAS NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393857 11.0 CM LONG ATTACHMENT MOTOR, DRILL, ELECTRIC-ATTACHMENT, PRODUCT CODE: HBC HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1