BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRAFTMAX CURVED GUIDE

    MDR report key: 7957757 · Received October 11, 2018

    Report

    Report Number
    1017294-2018-00163
    Event Type
    Malfunction
    Date Received
    October 11, 2018
    Date of Event
    September 20, 2018
    Report Date
    November 27, 2018
    Manufacturer
    CONMED CORPORATION
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXAMINATION OF THE RETURNED USED DEVICE, KS-CDG, CURVED GRAFTMAX GUIDE, CONFIRMED THE REPORTED PROBLEM. THE CURVED SHAFT GUIDE WAS DETACHED FROM THE CURVED HANDLE. HOWEVER, INSPECTED BOTH SHAFT AND THE HANDLE FOR THE CRITICAL DIMENSIONS AND COULD NOT FIND ANY ISSUES. EXCESSIVE TWISTING FORCES MAY HAVE ATTRIBUTED TO THIS FAILURE. THE MANUFACTURING DOCUMENTS FROM THE DEVICE HISTORY RECORD HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THE PRODUCT. THE PRODUCT RELEASED FOR DISTRIBUTION WAS FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF ONE COMPLAINT, REGARDING ONE DEVICE FOR THIS FAMILY AND FAILURE MODE. DURING THE SAME TIME FRAME 5,070 DEVICES HAVE BEEN MANUFACTURED AND SHIPPED WORLDWIDE. SHOULD ALL THE COMPLAINT DEVICES HAVE BEEN FOUND CONFIRMED FOR THIS REPORTED FAILURE, THE RATE OF FAILURE WOULD BE .0002 PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING; -AVOID LATERAL LOADING, DO NOT USE EXCESSIVE FORCE ON INSTRUMENTS TO AVOID DAMAGE OR BREAKAGE DURING USE. - AVOID UNINTENDED CONTACT WITH OTHER SURGICAL INSTRUMENTS DURING USE TO PREVENT DAMAGE OR BREAKAGE. - INSPECT THE INSTRUMENT AFTER USE TO ENSURE IT HAS NOT BEEN DAMAGED. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY

    Additional Manufacturer Narrative · 1

    THE DEVICE IS BEING RETURNED TO CONMED FOR EVALUATION. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE DEVICE EVALUATION AND COMPLAINT INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE GRAFTMAX CURVED GUIDE, KS-CDG FELL APART WHILE INSERTING INTO THE JOINT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) PROCEDURE ON (B)(6) 2018. THERE WAS NO REPORTED PATIENT INJURY AND A TWO-MINUTE DELAY IN SURGERY. THE SURGERY WAS COMPLETED USING A FEMORAL OFFSET GUIDE. THIS REPORT IS BEING RAISED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796768 GRAFTMAX CURVED GUIDE ACL GUIDE FZX CONMED CORPORATION 201515AA

    Patients

    Seq Age Sex Outcome Treatment
    1