BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.0CM SHORT ATTACHMENT

    MDR report key: 3811847 · Received October 11, 2013

    Report

    Report Number
    1045834-2013-03774
    Event Type
    Malfunction
    Date Received
    October 11, 2013
    Date of Event
    October 21, 2011
    Report Date
    November 2, 2011
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY DEPUY SYNTHES POWER TOOLS. THE DEVICE WAS EVALUATED AND THE COMPLAINT OF "HARD TO PUT ON AND REMOVE FROM MOTOR" WAS NOT CONFIRMED. THE SHORT 5.0CM SHORT ATTACHMENT MEETS MANUFACTURER'S SPECIFICATIONS, NO PROBLEM FOUND. THE ISSUES REGARDING ATTACHING TO A MOTOR ARE MOST LIKELY RELATED TO THE MOTOR IN USE WITH ATTACHMENT. 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 WAS "HARD TO PUT ON AND REMOVE FROM MOTOR" DURING SURGERY. IT IS KNOWN THAT DEVICE WAS BEING USED DURING SURGERY BUT NO PATIENT OR USER INJURY OCCURRED. IT IS UNKNOWN IF A DELAY IN THE SURGICAL PROCEDURE OCCURRED AS A RESULT OF THE DEVICE ISSUE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523740 5.0CM SHORT ATTACHMENT MOTOR, DRILL, ELECTRIC - ATTACHMENT HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1