BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEAR-CANNULA SYSTEM

    MDR report key: 1061632 · Received June 17, 2008

    Report

    Report Number
    1221934-2008-00313
    Event Type
    Malfunction
    Date Received
    June 17, 2008
    Date of Event
    June 10, 2008
    Report Date
    June 10, 2008
    Manufacturer
    DEPUY MITEK
    Product Code
    NBH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, WE ARE WAITING FOR FURTHER INFO BEFORE WE CAN DRAW ANY CONCLUSIONS ON THIS CASE.

    Description of Event or Problem · 1

    THE SALES REP REPORTED DURING A SHOULDER ARTHROSCOPY PROCEDURE, THE SURGEON WAS USING A 5.5 SMITH & NEPHEW BURR AND BROKE THE DAM ON THE CLEAR CANNULA, A PIECE OF PLASTIC FELL INTO THE PT. THE SURGEON REMOVED THE PIECE OF PLASTIC FROM THE PT AND COMPLETED THE PROCEDURE WITH NO PT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEAR-CANNULA SYSTEM ARTHROSCOPIC ACCESSORY NBH DEPUY MITEK 214120 5970025

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK