BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXETER CONTEMPORARY RIM CUTTER

    MDR report key: 3311850 · Received August 27, 2013

    Report

    Report Number
    0002249697-2013-02851
    Event Type
    Malfunction
    Date Received
    August 27, 2013
    Date of Event
    August 6, 2013
    Report Date
    August 6, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: MANUFACTURING DATE. AN EVENT REGARDING DAMAGE INVOLVING AN EXETER CONTEMPORARY RIM CUTTER WAS REPORTED. IT WAS REPORTED THAT THE SPRING BALL LOCKING MECHANISM FOR THE SLEEVE CAME APART. THE EVENT WAS REPORTED DURING A DEMONSTRATION BY THE SALES REP. THERE WAS NO ASSOCIATED PROCEDURE OR PATIENT INVOLVEMENT. THE DEVICE WAS RETURNED AND IT WAS CONFIRMED THAT THE PUSH BUTTON WAS LOOSE AND THE SPRING HAD MOVED POSITION WHICH LEAD TO THE DEVICE NOT FUNCTIONING AS EXPECTED. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    WHILST DEMONSTRATING DISASSEMBLY AND CLEANING OF RIM CUTTER HANDLE CAT NO. 6309-5-100 THE SPRING BALL LOCKING MECHANISM FOR THE SLEEVE CAME APART. THIS DEMO WAS USING THE RIM CUTTER THAT WAS CONSIGNED AT THE HOSPITAL LOCATION.

    Description of Event or Problem · 1

    WHILST DEMONSTRATING DISASSEMBLY AND CLEANING OF RIM CUTTER HANDLE CAT NO. 6309-5-100 THE SPRING BALL LOCKING MECHANISM FOR THE SLEEVE CAME APART. THIS DEMO WAS USING THE RIM CUTTER THAT WAS CONSIGNED AT THE HOSPITAL LOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418700 EXETER CONTEMPORARY RIM CUTTER INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH G3136462

    Patients

    Seq Age Sex Outcome Treatment
    1 Other