BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITOTAL TIBIAL IMPACTOR TIP

    MDR report key: 3002585 · Received February 13, 2013

    Report

    Report Number
    3004153240-2013-00016
    Event Type
    Malfunction
    Date Received
    February 13, 2013
    Report Date
    January 14, 2013
    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 THAT WERE REMOVED FROM ITOTAL REUSABLE INSTRUMENT TRAYS DURING RE-PROCESSING WAS COMPLETED. THE REVIEW SHOWED THAT FIVE TIBIAL IMPACTOR TIPS BROKE WHERE THE IMPACTOR TIP CONNECTS TO THE HANDLE. FOUR IMPACTOR HANDLES HAD THE BROKEN CONNECTOR OF THE IMPACTOR TIP LODGED INSIDE THE IMPACTOR HANDLE. REVIEW OF INSPECTION RECORDS FOR THE AFFECTED LOTS INDICATES THAT THE IMPACTOR TIPS WERE MANUFACTURED TO SPECIFICATION.

    Description of Event or Problem · 1

    PERIODIC REVIEW OF ITEMS THAT WERE REMOVED FROM ITOTAL REUSABLE INSTRUMENT TRAYS DURING RE-PROCESSING WAS COMPLETED. THE REVIEW SHOWED THAT FIVE TIBIAL IMPACTOR TIPS BROKE WHERE THE IMPACTOR TIP CONNECTS TO THE HANDLE. FOUR IMPACTOR HANDLES HAD THE BROKEN CONNECTOR OF THE IMPACTOR TIP LODGED INSIDE THE IMPACTOR HANDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64219 ITOTAL TIBIAL IMPACTOR TIP REUSABLE IMPACTOR TIP LXH CONFORMIS, INC. G1219, G1210, H1129

    Patients

    Seq Age Sex Outcome Treatment
    1