BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMK FEMORAL CUTTING GUIDE

    MDR report key: 1994327 · Received January 14, 2011

    Report

    Report Number
    3005180920-2010-00041
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    September 21, 2010
    Report Date
    January 12, 2011
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON FAILURE ANALYSIS, IT WAS CONFIRMED THAT THE FEMORAL CUTTING GUIDE WAS BROKEN. A DOCUMENT REVIEW OF THE LOT 096775 ((B)(4)) WAS PERFORMED AND NO PARTICULAR ISSUES WERE FOUND RELATED TO THE ADVERSE EVENT HAPPENED. NO OTHER SIMILAR EVENT WAS REPORTED CONCERNING THIS LOT. THE BREAKAGE IS THOUGHT TO BE ASSOCIATED TO AN IMPROPER USE: HAMMER HITS WERE PROBABLY DONE BY THE SURGEON IN ORDER TO ASSURE A CLOSE CONTACT BETWEEN THE CUTTING GUIDE AND THE DISTAL CUT. REPEATED HAMMER HITS COULD HAVE WEAKENED THE INSTRUMENT, LEADING TO ITS BREAKAGE. ON THE BASIS OF MEDACTA'S RISK ANALYSIS, THE FAILURE MODE IS 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.

    Description of Event or Problem · 1

    THE INSTRUMENT INVOLVED IS A GMK FEMORAL CUTTING GUIDE 4/1 #5 ((B)(4), LOT 096775). THE CUTTING GUIDE BROKE DURING SURGERY. FURTHER INVESTIGATION NEEDED TO DETERMINE THE ROOT CAUSE OF THE EVENT. NO PATIENT/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 NA 096775

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK