BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8CM ANGLE ATTACHMENT

    MDR report key: 3928655 · Received June 10, 2014

    Report

    Report Number
    1045834-2013-16428
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    October 11, 2011
    Report Date
    October 11, 2011
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY DEPUY SYNTHES POWER TOOLS. THE DEVICE WAS EVALUATED, AND DURING SERVICE THE DEVICE FAILED THE TEMPERATURE TEST. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM (B)(6), STATING THAT SERVICE WAS REQUIRED FOR THE DEVICE. DURING SERVICE, HEAT WAS NOTED. THE DEVICE WAS NOT BEING USED IN SURGERY. IT IS UNKNOWN IF INJURY OR MEDICAL INTERVENTION OCCURRED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340346 8CM ANGLE ATTACHMENT SURGICAL DRILL ATTACHMENT HBC THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1