BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMK FEMORAL CUTTING GUIDE SIZE 6

    MDR report key: 3192580 · Received June 21, 2013

    Report

    Report Number
    3005180920-2013-00070
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 20, 2013
    Report Date
    June 19, 2013
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    A DOCUMENT REVIEW OF THE LOT 096136 (14 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 PATIENT HARM SINCE, ALSO IN CASE OF BREAKAGE, THE CUTS COULD BE PERFORMED BECAUSE THE GUIDE IS FIXED TO THE BONE WITH THE PINS. THIRTY ONE SIMILAR EVENTS WERE REPORTED TO FDA: A FOLLOW-UP TO EXPLAIN THE MODIFICATION/ADJUSTMENT DECIDED, WAS ALREADY SENT TO THE (B)(4) 2011. THE FOLLOW-UP IS APPLICABLE ALSO TO THIS EVENT.

    Description of Event or Problem · 1

    THE FEMORAL CUTTING GUIDE BROKE OFF IN 2 PARTS DURING POSITIONING, SLIGHTLY BEATING WITH A MALLET. REFERENCE IMPORTER REPORT NUMBER 3006639916-2013-00070.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282446 GMK FEMORAL CUTTING GUIDE SIZE 6 REUSABLE SURGICAL INSTRUMENT FOR KNEE LXH MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK