BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMK FEMORAL CUTTING GUIDE

    MDR report key: 2111039 · Received May 5, 2011

    Report

    Report Number
    3005180920-2011-00021
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Date of Event
    April 14, 2011
    Report Date
    May 5, 2011
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A DOCUMENT REVIEW OF THE LOT 105114 (30 PIECES) WAS DONE AND NO ANOMALIES WERE FOUND RELATED TO THE PROBLEM OCCURRED. TWO OTHER SIMILAR EVENT WERE REPORTED CONCERNING THIS LOT (FDA REPORTS (B)(4)). 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, AS HAPPENED IN THIS CASE. FOURTEEN SIMILAR EVENTS WERE REPORTED TO FDA: 2010-00035; 2010-00040; 2010-00041; 2010-00042; 2010-00046; 2010-00047; 2011-00004; 2011-00005; 2011-00006; 2011-00010; 2011-00014; 2011-00016; 2011-00017; 2011-00018. AND A F/U TO EXPLAIN THE MODIFICATION/ADJUSTMENT DECIDED, WAS ALREADY SENT ON THE (B)(6) 2011. THE F/U IS APPLICABLE ALSO TO THIS EVENT.

    Description of Event or Problem · 1

    THE CUTTING GUIDE BROKE DURING IMPACTION. NO PT/USER HARM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GMK FEMORAL CUTTING GUIDE REUSABLE SURGICAL INSTRUMENT FOR KNEE JWH MEDACTA INTERNATIONAL SA 105114

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK