BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMK FEMORAL CUTTING GUIDE SIZE 6

    MDR report key: 2725007 · Received August 30, 2012

    Report

    Report Number
    3005180920-2012-00048
    Event Type
    Malfunction
    Date Received
    August 30, 2012
    Date of Event
    August 7, 2012
    Report Date
    August 30, 2012
    Manufacturer
    MEDACATA INTERNATIONAL SA
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A DOCUMENT REVIEW OF THE LOT 097369 (10 ITEMS) WAS DONE AND NO ANOMALIES WERE FOUND RELATED TO THE PROBLEM OCCURRED. NO SIMILAR EVENTS CONCERNING THIS LOT WERE REPORTED TO THE MANUFACTURER. THE BREAKAGE IS THOUGHT TO BE ASSOCIATED TO AN IMPROPER USE DURING PREVIOUS SURGERIES: IN ORDER TO ASSURE A CLOSE CONTACT BETWEEN THE CUTTING GUIDE AND THE DISTAL CUT, HAMMER HITS WERE PROBABLY DONE BY THE SURGEON AND THESE HAVE PROGRESSIVELY WEAKENED THE PIECE LEADING TO ITS BREAKAGE. ON THE BASIS OF MEDACTA'S RISK ANALYSIS, THE FAILURE MODE IS HIGH UNLIKELY TO CAUSE PT HARM SINCE, ALSO IN CASE OF BREAKAGE, THE CUTS COULD BE PERFORMED BECAUSE THE GUIDE IS FIXED TO THE BONE WITH THE PINS. TWENTY-EIGHT SIMILAR EVENTS WERE REPORTED TO FDA: 2010-00035; 2010-00040; 2010-00041; 201010-00042; 2010-00046; 2010-00047; 2011-00004; 2011-0005; 2011-00006; 2011-00010; 2011-00014; 2011-00016; 2011-00017; 2011-00018; 2011-00021; 2011-00028; 2011-00034; 2011-00035; 2011-00036; 2011-00040; 2011-00044; 2011-00051; 2011-00054; 2011-00056; 2011-00056; 2012-00012; 2012-00025; 2012-00026 AND A FOLLOW-UP TO EXPLAIN THE MODIFICATION/ADJUSTMENT DECIDED, WAS ALREADY SENT ON THE 3RD OF FEBRUARY 2011. THE FOLLOW-UP IS APPLICABLE ALSO TO THIS EVENT.

    Description of Event or Problem · 1

    THE CUTTING GUIDE IS CRACKED. THE PROBLEM WAS DETECTED DURING INSPECTION IN MEDACTA USA WAREHOUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GMK FEMORAL CUTTING GUIDE SIZE 6 REUSABLE SURGICLA INSTRUMETN FOR KNEE. JWH MEDACATA INTERNATIONAL SA 097369

    Patients

    Seq Age Sex Outcome Treatment
    1