BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20 DEG ANGLE DRIVER

    MDR report key: 2980094 · Received February 21, 2013

    Report

    Report Number
    1045834-2013-00292
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    December 1, 2013
    Report Date
    December 25, 2013
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    HBE
    PMA / PMN Number
    K042783
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED BY ANSPACH. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. REF: (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA STATING THAT THE DEVICE "CANNOT MOVE THE SELECTOR TO THE TUBE POSITION. IT WAS UNKNOWN TO THE REPORTER WHETHER OR NOT THE DEVICE WAS USED IN SURGERY. IT WAS ALSO UNKNOWN TO THE REPORTER WHETHER OR NOT ANY INJURIES OR MEDICAL INTERVENTION WERE REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75087 20 DEG ANGLE DRIVER HBE THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1