BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL BROACH HANDLE

    MDR report key: 3887921 · Received June 23, 2014

    Report

    Report Number
    1818910-2014-21655
    Event Type
    Injury
    Date Received
    June 23, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 4, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ON JULY 11TH, 2014 (B)(4) ADVISED THAT THE INSTRUMENT WAS RETURNED AND EVALUATED BY (B)(4). ON ASSESSMENT, THE BROACH HANDLES ENGAGED CORRECTLY ONTO THE FEMORAL RASP TRIAL. NO ISSUES WERE NOTED ON ANY OF THE INSTRUMENTS. THE DIMENSIONS OF THE FEMORAL RASP TRIAL AND THE ENGAGEMENT HOLE ON THE BROACH HANDLE WERE MEASURED. THE OUTSIDE DIMENSION OF THE FEMORAL RASP SPIGOT MEASURES 6.97MM. THE DRAWING SPECIFICATIONS ARE:- UPPER LIMIT 7.025MM:-LOWER LIMIT 6.939MM. THE FEMORAL RASP SPIGOT DIAMETER OF THE PRODUCT COMPLAINT FEMORAL RASP IS WITHIN ITS SPECIFICATION. THE BROACH HANDLES DIAMETER MEASURES 7.02MM ON BOTH. THE DRAWING SPECIFICATION FOR THE BROACH HANDLE ENGAGEMENT HOLE IS:- LOWER LIMIT 7.00MM:-UPPER LIMIT 7.036MM. THE BROACH HANDLE ENGAGEMENT HOLES ARE WITHIN DRAWING SPECIFICATION. AS THE INSTRUMENTS ARE WITHIN INITIAL SPECIFICATION AND ARE FULLY FUNCTIONAL, THESE WILL BE RETURNED TO CIRCULATION. THE INVESTIGATION IS NOT ABLE TO DETERMINE A ROOT CAUSE FOR THE PROBLEMS EXPERIENCED. BASED ON THE INVESTIGATION THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. 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 IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    PROCEDURE: HIP REVISION (NON-DEPUY). CORAIL BROACH HANDLE WOULD NOT RE-ENGAGE WITH TRIAL STEM. PROCEDURE WAS COMPLETED USING A SUMMIT BROACH HANDLE TO REMOVE THE TRIAL STEM. CASE WAS DELAYED BY 45 MINUTES TO AN HOUR AS THE SURGEON TRIED TO REMOVE THE TRIAL STEM. PATIENT WAS UNDER ANAESTHESIA (NOT SURE IF GENERAL OR SPINE). NO ADVERSE EVENT TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364928 CORAIL BROACH HANDLE HIP INSTRUMENT/TRIAL LXH DEPUY ORTHOPAEDICS, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1