BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMK EFFICIENCY SPHERE TIBIAL OFFSET HANDLE

    MDR report key: 4959765 · Received July 30, 2015

    Report

    Report Number
    3005180920-2015-00158
    Event Type
    Malfunction
    Date Received
    July 30, 2015
    Report Date
    October 29, 2015
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    LXH
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 29 SEPTEMBER 2015 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT. ON 28 OCTOBER 2015 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON JULY 29, 2015: LOT 151235: (B)(4) ITEMS MANUFACTURED AND RELEASED ON MARCH 11, 2015. NO ANOMALIES FOUND. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED ISSUE. VISUAL INSPECTION ON THE RETRIEVED ITEM MADE BY (B)(4) ON JULY 29, 2015: FROM A VISUAL INSPECTION, IT LOOKS THAT THE HANDLE HAS ONE OF THE 'CLIPPING ARM' BROKEN. NO OTHER ANOMALIES HAS BEEN NOTED. LOOKING AT THE PIECES IT ISN'T POSSIBLE TO UNDERSTAND THE ROOT CAUSE. AS FURTHER ANALYSIS WE TRIED SUCCESSFULLY TO COUPLE ONE HANDLE (REF. 77.11.0019 - SAME BATCH OF THE OBJECT OF THE COMPLAINT) TO THE TRIAL INSERT. NO ANOMALIES IN THE FUNCTIONALITY WERE FOUND BOTH IN THE CLIPPING AND DE-CLIPPING PHASE OF THE HANDLE TO THE INSERT. AS DESCRIBED IN THE COMPLAINT, IT SEEMS THAT THE HANDLE BROKE DURING THE POSITIONING AND FIXING OF THE INSERT IN THE BASEPLATE. WE CAN ONLY SUPPOSE THAT THE SURGEON DIDN'T FEEL THAT INSERT WAS ALREADY CLIPPED ON THE BASEPLATE AND APPLIED EXCESSIVE FORCE THAT CAUSE THE BREAKAGE OF THE HANDLE.

    Description of Event or Problem · 1

    IMP # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495903 GMK EFFICIENCY SPHERE TIBIAL OFFSET HANDLE SURGICAL INSTRUMENT FOR KNEE LXH MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1