BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20 DEGREE ANGLE DRIVER

    MDR report key: 3063208 · Received April 11, 2013

    Report

    Report Number
    1045834-2013-01591
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 18, 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 BEEN RECEIVED BY ANSPACH. THE DEVICE WAS EVALUATED AND FAILED THE TEMPERATURE ACCEPTANCE TEST (OVER HIGH LIMIT). EVIDENCE SUGGESTS THIS WAS DUE TO USAGE/WEAR OVER TIME. THE EVENT WAS CONFIRMED. IF ADD'L INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA STATING THAT THE DEVICE WAS "OVERHEATING" DURING TESTING. THE DEVICE WAS NOT USED IN SURGERY. THERE WERE NO INJURIES OR MEDICAL INTERVENTION REPORTED. THERE WAS NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154174 20 DEGREE ANGLE DRIVER HBE THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1