BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX K2 BROACH

    MDR report key: 770919 · Received August 7, 2006

    Report

    Report Number
    1226188-2006-00004
    Event Type
    Malfunction
    Date Received
    August 7, 2006
    Date of Event
    May 5, 2006
    Report Date
    June 27, 2006
    Manufacturer
    OMNI LIFE SCIENCE, INC.
    Product Code
    HTQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON EVAL OF THE RETURNED DEVICE, THE TIP HAD BROKEN OFF AT THE FIRST LARGE TOOTH. WE WILL BE MOVING TO A FINER PITCH TOOTH FOR FUTURE ORDERS.

    Description of Event or Problem · 1

    THE TIP OF A K2 BROACH, BROKE OFF DURING TOTAL HIP REPLACEMENT SURGERY. THE BROKEN PART WAS SUCCESSFULLY RETRIEVED BY THE SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX K2 BROACH SURGICAL INSTRUMENT FOR THA HTQ OMNI LIFE SCIENCE, INC. SIZE 2 BROACH L0405

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention