BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORAIL2 ANTERIOR BROACH HANDLE

    MDR report key: 3832002 · Received May 27, 2014

    Report

    Report Number
    1818910-2014-19440
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 27, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    EXAMINATION AND FUNCTIONAL TESTING OF THE RETURNED DEVICE CONFIRMS THE REPORTED EVENT THAT THE HANDLE DOES NOT LOCK DOWN ON THE BROACHES. THE OVERALL CONDITION OF THE BROACH HANDLES SUGGESTS HEAVY USAGE AS THE DEVICE EXHIBITS SEVERAL GOUGES/SCRATCHES. BASED ON EVIDENCE OF HEAVY USAGE, THE ROOT CAUSE IS ATTRIBUTED TO PRODUCT WEAR OUT. BASED ON THE ROOT CAUSE OF PRODUCT WEAR OUT, CORRECTIVE ACTION IS NOT NEEDED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    INSTRUMENTS DO NOT LOCK ON BROACHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310786 CORAIL2 ANTERIOR BROACH HANDLE HIP INSTRUMENT/TRIAL LXH DEPUY ORTHOPAEDICS, INC. 1818910 J0608

    Patients

    Seq Age Sex Outcome Treatment
    1