BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMK FEMORAL CUTTING GUIDE

    MDR report key: 2007280 · Received February 25, 2011

    Report

    Report Number
    3005180920-2011-00010
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    February 3, 2011
    Report Date
    February 25, 2011
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A DOCUMENT REVIEW OF THE LOT 096003 (9 PIECES) WAS DONE AND NO ANOMALIES WERE FOUND RELATED TO THE PROBLEM OCCURRED. NO OTHER SIMILAR EVENT WAS REPORTED CONCERNING THIS LOT. 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 THE SMALL CRACK POINTED OUT IN THIS EVENT. ON THE BASIS OF (B)(6) 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. NINE SIMILAR EVENTS WERE REPORTED TO FDA: 2010-00035; 2010-00040; 2010-00041; 2010-00042; 2010-00046; 2010-00047; 2011-00004; 2011-00005; 2011-00006; AND A FOLLOW-UP TO EXPLAIN THE MODIFICATION/ADJUSTMENT DECIDED, WAS ALREADY SENT ON THE (B)(6) 2011. THIS FOLLOW UP IS APPLICABLE ALSO TO THIS EVENT.

    Description of Event or Problem · 1

    A SMALL CRACK ON THE SIDE OF THE AP REF - FEMORAL CUTTING GUIDE 4/1 - #4 WAS NOTICED DURING SURGERY AS THE SURGEON WAS SETTING THE CUTTING GUIDE IN PLACE. A MALLET WAS NOT USED, AND SO THE SALES REP WAS NOT SURE IF THE CRACK OCCURRED PRIOR TO THE SURGERY OR DURING THE SURGERY. HE SAID THAT HE INSPECTED IT PRIOR TO SURGERY BUT DID NOT NOTICE ANYTHING. THE SURGEON COMPLETED MAKING THE CUTS WITH THE CRACKED CUTTING GUIDE AND 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 096003

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK