BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPACTOR HEAD ASSEMBLY

    MDR report key: 3940957 · Received April 23, 2014

    Report

    Report Number
    3004153240-2014-00045
    Event Type
    Malfunction
    Date Received
    April 23, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 4, 2014
    Manufacturer
    CONFORMIS, INC.
    Product Code
    LXH
    PMA / PMN Number
    CLASS 1
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PERIODIC REVIEW OF ITEMS REMOVED FROM REUSABLE INSTRUMENT TRAYS DURING RE-PROCESSING WAS COMPLETED. REVIEW SHOWED THAT ONE FEMORAL IMPACTOR HEAD HAD BROKEN AT THE POINT WHERE THE TIP CONNECTS TO THE IMPACTOR HANDLE. THERE IS NO INDICATION THAT A SURGERY WAS ADVERSELY IMPACTED. REVIEW OF INSPECTION RECORDS FOR THE AFFECTED LOT INDICATE THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION.

    Description of Event or Problem · 1

    PERIODIC REVIEW OF ITEMS REMOVED FROM REUSABLE INSTRUMENT TRAYS DURING RE-PROCESSING WAS COMPLETED. REVIEW SHOWED THAT ONE FEMORAL IMPACTOR HEAD HAD BROKEN AT THE POINT WHERE THE TIP CONNECTS TO THE IMPACTOR HANDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245496 IMPACTOR HEAD ASSEMBLY REUSABLE INSTRUMENT COMPONENT LXH CONFORMIS, INC. C130701

    Patients

    Seq Age Sex Outcome Treatment
    1