BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMK REVISION OFFSET ADAPTER 5MM

    MDR report key: 7276206 · Received February 16, 2018

    Report

    Report Number
    3005180920-2018-00046
    Event Type
    Malfunction
    Date Received
    February 16, 2018
    Date of Event
    January 15, 2018
    Report Date
    May 17, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INSTRUCTIONS FOR QUALITY CONTROL WERE UPDATED WITH A SPECIFIC VISUAL CONTROL AFTER PRODUCTION AND A FUNCTIONAL CONTROL DURING THE PACKAGING ACTIVITY.

    Additional Manufacturer Narrative · 0

    METROLOGICAL ANALYSES PERFORMED ON 28 FEBRUARY 2018 BY QUALITY CONTROL DEPARTMENT A BURR HAS BEEN DETECTED ON THE IMPLANT. THE IMPLANT CIRCUMFERENCE ON THE BURR AREA IS 15,68MM OUT OF TOLERANCE, BECAUSE IN THAT CIRCUMFERENCE SHOULD BE 15.50 ±0,05MM. VISUAL INSPECTION DONE ON 27TH FEBRUARY 2018 BY R&D PRODUCT MANAGER: THE VISUAL INSPECTION CONFIRMS THE PRESENCE OF A LITTLE BURR ON THE TOP EDGE OF THE OFFSET CONNECTOR; THIS BURR CAUSED AN INCREMENT OF THE DIAMETER Ø15.5±0.05 TILL Ø15,68. IN THIS SITUATION IT IS NOT ALLOWED A CORRED INSERTION OF THE OFFSET IMPLANT INTO THE CONNECTOR. IT IS NOT POSSIBLE TO ESTABLISH THE REAL CAUSE OF THE BURR THAT COULD HAVE BEEN CAUSED TO A IMPROPER COLLISION WITH OTHER METAL PIECES BEFORE OR DURING SURGERY. SINCE THE CONTROL PLAN OF THIS PIECE DOES NOT ALLOW TO DETECT EVENTUAL PRESENCE OF BURR ON THE TOP EDGE OF THE INSTRUMENT (CONTROL CURRENTLY DONE WITH 3D CONTROL MACHINE) WE DECIDED TO IMPLEMENT THE INSTRUCTION CONTROL INTRODUCING FUNCTIONAL CHECK WITH SPECIFIC GO NO-GO GAUGE.

    Additional Manufacturer Narrative · 1

    THE ASSOCIATED IMPLANT INVOLVED IN THE CASE IS THE GMK REVISION OFFSET CONNECTOR 5 MM REFERENCE 02.07.0005 (K102437) LOT. 161800 DOCUMENT REVIEW PERFORMED ON 14 FEBRUARY 2018: LOT 1550970: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18 JANUARY 2016. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, NO SIMILAR EVENTS REPORTED ON ITEMS OF THE SAME LOT. LOT 161800: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15 APRIL 2016. EXPIRATION DATE: 2021-03-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ONE ANY SIMILAR REPORTED EVENT. PRELIMINARY INVESTIGATION PERFORMED ON 14 FEBRUARY 2018 BY R&D PROJECT MANAGER: SURGEON WAS UNABLE TO INSERT THE 5MM OFFSET IMPLANT INTO THE DEDICATED 5MM OFFSET ADAPTER. THE SHAPE AND DIMENSION OF THE OFFSET ADAPTER IS DESIGNED TO ALWAYS ALLOW THE PROPER INSERTION OF BOTH TRIAL AND IMPLANT 5 MM OFFSET. EVERY INSTRUMENT IS DIMENSIONALLY AND FUNCTIONALLY CHECKED BEFORE SHIPPING; THE EXTERNAL PROFILE OF THE OFFSET IMPLANT IS DIMENSIONALLY CHECKED TOO. FOR THIS REASON WE CAN SUPPOSE THE PROBLEM IS RELATED TO A LITTLE DAMAGE TO THE INTERNAL PROFILE OF THE 5 MM OFFSET ADAPTER. A MORE DETAILED EXPLANATION ON THE CAUSE OF COMPLAIN WILL BE REPORTED AFTER HAVING ANALYZED AND MEASURED THE RETURNED PIECE. (DEVICES NOT RETURNED YET).

    Description of Event or Problem · 1

    AT THE FINAL STAGE OF THE REVISION TKR, SURGEON WAS UNABLE TO CONNECT THE OFFSET 5 MM TO ITS POSITIONING TOOL BECAUSE IT DIDN'T FIT WITH THE SIZES. AFTER FEW ATTEMPTS DECIDED TO SWITCH TO THE 3 MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122339 GMK REVISION OFFSET ADAPTER 5MM SURGICAL INSTRUMENT FOR KNEE LXH MEDACTA INTERNATIONAL SA 161800

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other