BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8CN ABGKE ATTACHMENT

    MDR report key: 3558877 · Received September 13, 2013

    Report

    Report Number
    1045834-2013-12457
    Event Type
    Malfunction
    Date Received
    September 13, 2013
    Report Date
    May 23, 2011
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY DEPUY SYNTHES. THE DEVICE WAS EVALUATED AND THE REPORTED PROBLEM OF "CUTTER COULD NOT BE INSERTED" WAS CONFIRMED. THE DEVICE DID NOT MEET ALL MANUFACTURING SPECIFICATIONS. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM (B)(6) STATING "CANNOT INSERT CUTTER." THE DEVICE WAS NOT BEING USED DURING SURGERY. IT IS UNKNOWN IF THERE WERE INJURIES OR MEDICAL INTERVENTION. THE DATE OF THE EVENT IS UNKNOWN. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463553 8CN ABGKE ATTACHMENT MOTOR, DRILL, ELECTRIC - ATTACHMENT, PRODUCT CODE: HBC HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1