BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20 DEGREE ANGLE DRIVER

    MDR report key: 3032798 · Received March 29, 2013

    Report

    Report Number
    1045834-2013-01068
    Event Type
    Malfunction
    Date Received
    March 29, 2013
    Date of Event
    August 3, 2011
    Report Date
    August 30, 2011
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    ERL
    PMA / PMN Number
    K965080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY ANSPACH. RELIABILITY ENGINEERING EVALUATED THE DEVICE. THE REPORTED PROBLEM WAS CONFIRMED; THE DEVICE EXCEEDED TEMPERATURE REQUIREMENTS. IT WAS DETERMINED THAT THE DEVICE HAD BEARING WEAR/DAMAGE, AND ALSO HAD DENTS AND DAMAGE ON THE DISTAL END OF THE ATTACHMENT THAT WAS INDICATIVE OF MISHANDLING OF THE DEVICE. THE BEARING DAMAGE COULD BE DUE TO NORMAL WEAR OUT OVER TIME, BUT MAY HAVE BEEN EXACERBATED BY IMPROPER OR INEFFECTIVE CLEANING AND MAINTENANCE OF THE DEVICE. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA STATING THE DEVICE WAS "OVERHEATING." THE DEVICE WAS NOT BEING USED DURING A PROCEDURE. NO PATIENT OR USER INJURIES WERE REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131030 20 DEGREE ANGLE DRIVER ERL THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1