BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 1892107 · Received November 3, 2010

    Report

    Report Number
    1038671-2010-00176
    Event Type
    Injury
    Date Received
    November 3, 2010
    Date of Event
    September 23, 2010
    Report Date
    November 3, 2010
    Manufacturer
    EXACTECH, INC.
    Product Code
    LXH
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEFORMATION OF THE THREADING ON BOTH THE MALE AND FEMALE PORTION OF THE CONNECTION INDICATES THE SCREW WAS CROSS-THREADED INTO THE HOLE. IT CANNOT BE DETERMINED IF THERE WAS A PROBLEM WITH THE LEAD-IT THREAD FORM ON EITHER THE MALE OR FEMALE COMPONENT, NOR CAN IT BE DETERMINED WHICH OF THE INSERTERS WAS USED FIRST. IT IS LIKELY THAT THE THREADS OF THE HUMERAL STEM TRIAL WERE DEFORMED WHEN THE FIRST INSERTER WAS CROSS-THREADED AND SUBSEQUENTLY DEFORMED THE THREADS OF THE SECOND INSERTER. THE DEVICE HISTORY RECORD REVIEW PROVIDES ASSURANCE THE PART WAS ACCEPTED WITH CONFORMANCE TO THE PRODUCT REQUIREMENTS.

    Description of Event or Problem · 1

    DURING SHOULDER ARTHROPLASTY THE STEM TRIAL STRIPPED 2 STEM INSERTERS. IMPLANT WOULD NOT THREAD INTO STEM WHICH CAUSED THE STEM TO SEAT INCORRECTLY RESULTING IN A DISTAL HUMERUS FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EQUINOXE PRIMARY STEM INSERTER/EXTRACTOR LXH EXACTECH, INC. 33653003

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention