BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PELVIC ARRAY ADAPTOR ASSY

    MDR report key: 6149585 · Received December 6, 2016

    Report

    Report Number
    3005985723-2016-00421
    Event Type
    Malfunction
    Date Received
    December 6, 2016
    Date of Event
    December 5, 2016
    Report Date
    January 17, 2017
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K143752
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT: THE REPORTED DEVICE WAS CONFIRMED TO BE A PELVIC ARRAY ADAPTOR ASSEMBLY, P/N 112240, LOT NUMBER 19260315 WHICH WAS REPORTED TO HAVE A BROKEN THREAD. DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION: VISUAL INSPECTION SHOWS NO DAMAGE TO THE PART. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION WAS NOT COMPLETED AS THE FUNCTIONAL INSPECTION WAS SUFFICIENT TO REFUTE THE COMPLAINT. FUNCTIONAL INSPECTION: THE ADAPTOR WAS THREADED ONTO A PELVIC ARRAY WITHOUT ISSUE. THE ASSOCIATED 112290 FEMORAL ARRAY COULD NOT THREAD INTO THE ADAPTOR INDICATING THAT THE ISSUE IS WITH IT AND NOT THE ADAPTOR. THE COMPLAINT AGAINST THE ADAPTOR WAS THEREFORE NOT CONFIRMED. SEE ATTACHED PICTURE. DEVICE HISTORY REVIEW: A REVIEW OF THE DEVICE HISTORY SHOWS THAT (B)(4) PARTS WERE RECEIVED, INSPECTED, AND ACCEPTED INTO STOCK MARCH 1, 2016 WITH NO FAILURES. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS RELATED TO P/N 112240, LOT NUMBER 19260315 SHOWS NO ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. THREE ADDITIONAL COMPLAINTS WERE FOUND FOR THE 112240 P/N; THEY ARE TRACKWISE PR# (B)(4). CONCLUSIONS: THE FAILURE MODE OF BROKEN THREAD ON THE PELVIC ARRAY ADAPTOR ASSEMBLY WAS NOT CONFIRMED. THE FAILURE WAS CONFIRMED ON THE ASSOCIATED 112290 FEMORAL ARRAY. THE ISSUE WAS NOTICED DURING A CASE BUT THERE WAS NO PATIENT INVOLVEMENT AND THE CASE WAS COMPLETED SUCCESSFULLY. CORRECTIVE ACTION/PREVENTIVE ACTION: NO FURTHER ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    AS PART OF NORMAL COMPLAINT FOLLOW-UP, AN EVALUATION OF THE EVENT HAS BEEN INITIATED BY MAKO SURGICAL. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE SURGEON WAS COMPLETING A TOTAL KNEE ARTHROPLASTY PROCEDURE WHEN HE NOTICED THE BROKEN THREADING ON 2 DEGREE OF FREEDOM ADAPTER. THE BROKEN THREADING WAS FOUND DURING BONE PIN PLACEMENT ON THE FEMUR.

    Description of Event or Problem · 1

    THE SURGEON WAS COMPLETING A TOTAL KNEE ARTHROPLASTY PROCEDURE WHEN HE NOTICED THE BROKEN THREADING ON 2 DEGREE OF FREEDOM ADAPTER. THE BROKEN THREADING WAS FOUND DURING BONE PIN PLACEMENT ON THE FEMUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798768 PELVIC ARRAY ADAPTOR ASSY STEREOTACTIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 19260315

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization