BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGLED ACET INSERTR

    MDR report key: 5474406 · Received March 2, 2016

    Doing adverse event research by hand?

    The Research Assistant searches MAUDE for you, groups reports by failure mode, and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Report

    Report Number
    1818910-2016-14466
    Event Type
    Malfunction
    Date Received
    March 2, 2016
    Date of Event
    February 25, 2016
    Report Date
    March 8, 2016
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HWR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION AND JUSTIFICATION STATUS: THE COMPLAINT STATES FEMORAL INTRODUCER SIDE KNOB BROKE OFF POST-SURGERY. THE INVESTIGATION CONFIRMED THE FAILURE MODE AS REPORTED. THE RETURNED DEVICE WAS TRANSFERRED TO BIOENGINEERING FOR REVIEW, A REPORT WAS RECEIVED STATING; BOTH FAILURE MODES; PATIENT HARM AND DELAY TO SURGERY HAVE BEEN ADEQUATELY COVERED IN THE RISK ASSESSMENT (DVA-105445-FDE) OF THE DEVICE AND NO FURTHER UPDATES ARE REQUIRED. THE COMPLAINT MENTIONS THAT THERE WAS NO SURGICAL DELAY AND NO PATIENT HARM HAS BEEN REPORTED. THE OPERATION OF THE RETURNED DEVICE WAS SMOOTH BY ROTATING THE CENTRAL THUMB WHEEL WITH NO INDICATION OF JAMMING. THE COMPLAINT SHALL BE CLOSED WITH AN UNDETERMINED CONCLUSION AND ENTERED INTO THE COMPLAINTS SYSTEM AND MONITORED THROUGH TREND ANALYSIS. IF FURTHER INFORMATION IS RECEIVED THE COMPLAINT SHALL BE REOPENED AND INVESTIGATED FURTHER. DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT REMAINS UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THE INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT REMAINS UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THE INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THE INVESTIGATION ONCE IT HAS BEEN COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DURING IMPACTION OF CUP A PART OF THE PLASTIC HANDLE BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130838 ANGLED ACET INSERTR HIP INSTRUMENT/TRIAL HWR DEPUY ORTHOPAEDICS, INC. PC30385001

    Patients

    Seq Age Sex Outcome Treatment
    1