BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOLOC(TM) 3DI MTP CUP/CONE REAMER

    MDR report key: 3120117 · Received May 20, 2013

    Report

    Report Number
    1043534-2013-00813
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    March 27, 2013
    Report Date
    April 8, 2013
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: DEVICE FAILURE OCCURRED AND WAS RELATED TO EVENT. THE COMPLAINT AND INVENTORY WERE REVIEWED. THE PRODUCT WAS DIMENSIONALLY INSPECTED AND PHOTOGRAPHIC IMAGES WERE MADE OF THE RETURNED PRODUCT. (B)(4).

    Additional Manufacturer Narrative · 1

    THIS IS A REPORTABLE MALFUNCTION. THE INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2013-00814.

    Description of Event or Problem · 1

    ALLEGEDLY REAMERS ARE RUSTING.PH LEVEL FOR DECONTAMINATION CLEANING - ENZYMATIC CLEANER METREX.TIME OF EXPOSURE WITH DETERGENT PRIOR TO RINSE: 1-2 HRS.TEMPERATURE OF BATH: APPROX. 110-120 DEGREE FAHRENHEIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222430 ORTHOLOC(TM) 3DI MTP CUP/CONE REAMER SMALL JOINT INSTRUMENT, CODE:HRS HRS WRIGHT MEDICAL TECHNOLOGY, INC. 1145402

    Patients

    Seq Age Sex Outcome Treatment
    1