BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    50CM SHORT ATTACHMENT

    MDR report key: 3811862 · Received October 11, 2013

    Report

    Report Number
    1045834-2013-05235
    Event Type
    Malfunction
    Date Received
    October 11, 2013
    Date of Event
    July 10, 2012
    Report Date
    July 10, 2012
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    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 ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4). NO FILES ATTACHED.

    Description of Event or Problem · 1

    A REPORT RECEIVED FROM THE USA STATED THE DEVICE EXPERIENCED A "CAN NOT ATTACH TO MOTOR" ISSUE DURING SURGERY. NO PATIENT OR USER INJURY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523760 50CM SHORT ATTACHMENT MOTOR, DRILL, ELECTRIC - ATTACHMENT HBC THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1