BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PELVIC ARRAY ASSY

    MDR report key: 6261062 · Received January 18, 2017

    Report

    Report Number
    3005985723-2017-00023
    Event Type
    Malfunction
    Date Received
    January 18, 2017
    Date of Event
    January 12, 2017
    Report Date
    February 21, 2017
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K141989
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT: THE REPORTED DEVICE IS A PELVIC ARRAY ASSY, CATALOG# 112230, LOT# 19030312 WHICH HAD A BROKEN SCREW. DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION: VISUAL INSPECTION OF THE ARRAY SHOWS THAT THE SCREW IS MISSING. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION WAS NOT COMPLETED AS THE VISUAL INSPECTION WAS SUFFICIENT TO CONFIRM THE FAILURE MODE. FUNCTIONAL INSPECTION: THE ARRAY SCREW BEING MISSING RENDERS THE ASSEMBLY UNUSABLE. DEVICE HISTORY REVIEW: A REVIEW OF THE DEVICE HISTORY RECORDS SHOWS THAT (B)(4) PARTS WERE RECEIVED, INSPECTED AND REJECTED ON NPR (B)(4) ON SEPTEMBER 5, 2012. THE FAILURES WERE UNRELATED TO THE FAILURE MODE IN THIS COMPLAINT. THE PARTS WERE RE-INSPECTED AND ACCEPTED SEPTEMBER 27, 2012. COMPLAINT HISTORY REVIEW: BASED ON THE DEVICE IDENTIFICATION, P/N 112240, LOT #19030312 , THE COMPLAINT DATABASES WERE REVIEWED FROM 2011 TO PRESENT FOR SIMILAR REPORTED EVENTS REGARDING A BROKEN SCREW. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT NUMBER REFERENCED. CONCLUSIONS: THE FAILURE MODE OF A BROKEN SCREW ON A PELVIC ARRAY WAS CONFIRMED. THE ROOT CAUSE OF THE FAILURE COULD NOT BE DETERMINED AS THE SCREW WAS NOT RETURNED. THE FAILURE OCCURRED DURING THE 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 COMPLETED A TOTAL HIP ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). THE PELVIC ARRAY SCREWS FROM TWO DIFFERENT TRAYS SNAPPED IN HALF. A THIRD PELVIC ARRAY SCREW HAD TO BE USED.

    Description of Event or Problem · 1

    THE SURGEON COMPLETED A TOTAL HIP ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). THE PELVIC ARRAY SCREWS FROM TWO DIFFERENT TRAYS SNAPPED IN HALF. A THIRD PELVIC ARRAY SCREW HAD TO BE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43810 PELVIC ARRAY ASSY STEREOTACTIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 19030312

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization