BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIBIAL INSERT IMPACTOR TIP

    MDR report key: 6529122 · Received April 28, 2017

    Report

    Report Number
    3004153240-2017-00087
    Event Type
    Malfunction
    Date Received
    April 28, 2017
    Date of Event
    February 1, 2017
    Report Date
    June 21, 2017
    Manufacturer
    CONFORMIS, INC.
    Product Code
    OOG
    PMA / PMN Number
    CLASS 1
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBERS: L142001, F160301, G131601, K150101, J160101, C160101.

    Additional Manufacturer Narrative · 1

    LOT NUMBERS: L142001, F160301, G131601, K150101, J160101, C160101. PERIODIC REVIEW OF ITEMS REMOVED FROM REUSABLE INSTRUMENT TRAYS DURING REPROCESSING WAS COMPLETED. REVIEW SHOWED THAT SIX TIBIAL INSERT IMPACTOR TIPS WERE BROKEN. REVIEW OF THE LOT HISTORY RECORDS INDICATE THAT THE DEVICES WERE MANUFACTURED TO SPECIFICATION. A CAUSE OF FAILURE CAN NOT BE CONCLUSIVELY DETERMINED FROM THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    PERIODIC REVIEW OF ITEMS REMOVED FROM REUSABLE INSTRUMENT TRAYS DURING REPROCESSING WAS COMPLETED. REVIEW SHOWED THAT SIX TIBIAL INSERT IMPACTOR TIPS WERE BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313224 TIBIAL INSERT IMPACTOR TIP REUSABLE IMPACTOR COMPONENT OOG CONFORMIS, INC. *SEE MFG NARRATIVE

    Patients

    Seq Age Sex Outcome Treatment
    1