BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.0CM SHORT ATTACHMENT

    MDR report key: 3811239 · Received October 11, 2013

    Report

    Report Number
    1045834-2013-04726
    Event Type
    Malfunction
    Date Received
    October 11, 2013
    Date of Event
    May 14, 2012
    Report Date
    May 14, 2012
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REC'D BY DEPUY SYNTHES. THE DEVICE IS CURRENTLY UNDERGOING EVAL. ONCE THE EVAL HAS BEEN COMPLETED OR IF ADD'L INFO IS REC'D, A SUPPLEMENTAL MDR WILL BE SENT. REF: (B)(4).

    Description of Event or Problem · 1

    REPORT REC'D FROM THE USA STATING THAT THE ATTACHMENT IS "OVERHEATING." THE DEVICE WAS BEING USED DURING SURGERY. NO INJURY OR MEDICAL INTERVENTION OCCURRED. THERE WAS NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523995 5.0CM SHORT ATTACHMENT MOTOR, DRILL, ELECTRIC - ATTACHMENT, PRODUCT CODE: HBC HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1