BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON/MODIFIED TRINKLE REAMER

    MDR report key: 2082116 · Received April 26, 2011

    Report

    Report Number
    1811755-2011-01413
    Event Type
    Malfunction
    Date Received
    April 26, 2011
    Date of Event
    March 29, 2011
    Report Date
    March 29, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    GET
    PMA / PMN Number
    K943323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION AS OF THE DATE OF THIS REPORT. THIS REPORT WILL BE UPDATED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A RED RESIDUE WAS NOTICED AT THE REAR CONNECTION POINT AFTER REMOVAL FROM THE DRYER DURING CLEANING. THERE WAS NO PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCE RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON/MODIFIED TRINKLE REAMER GET STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK