BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PELVIC ARRAY ADAPTOR ASSY

    MDR report key: 6200585 · Received December 22, 2016

    Report

    Report Number
    3005985723-2016-00452
    Event Type
    Malfunction
    Date Received
    December 22, 2016
    Date of Event
    December 20, 2016
    Report Date
    February 13, 2017
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K141989
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT: THE REPORTED DEVICE WAS A PELVIC ARRAY ADAPTOR ASSY, CATALOG# 112240, LOT # 19020514 THAT THE SCREW WAS BROKEN OFF IN THE MATING COMPONENT. DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION OF THE ADAPTOR CLEARLY SHOWS THAT THE SCREW IS THREADED INTO AND BROKEN OFF IN THE ASSOCIATED 111430 CLAMP. THE SCREW CANNOT BE UNTHREADED RENDERING BOTH PARTS UNUSABLE. THE FAILURE IS CONSISTENT WITH THE SCREW CROSS THREADING IN THE CLAMP AND THEN EXCESSIVE TORQUE APPLIED TO IT CAUSING IT TO BREAK. DEVICE HISTORY REVIEW: A REVIEW OF THE DEVICE HISTORY RECORDS SHOWS THAT (B)(4) PARTS WERE RECEIVED, INSPECTED, AND ACCEPTED ON AUGUST 29, 2014 WITH NO FAILURES. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS RELATED TO P/N 112240, LOT #19020514 SHOWS NO ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSIONS: THE FAILURE MODE OF A BROKEN SCREW ON A PELVIC ARRAY ADAPTOR ASSEMBLY WAS CONFIRMED. THE ISSUE OCCURRED DURING A CASE HOWEVER, THERE WAS NO DELAY, NO HARM TO THE PATIENT, 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 HIP ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). AS THE DOCTOR WAS TIGHTENING THE PELVIC ARRAY WITH THE SQUARE DRIVER, THE ADAPTER BROKE OFF.

    Description of Event or Problem · 1

    THE SURGEON WAS COMPLETING A TOTAL HIP ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). AS THE DOCTOR WAS TIGHTENING THE PELVIC ARRAY WITH THE SQUARE DRIVER, THE APADATER BROKE OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848834 PELVIC ARRAY ADAPTOR ASSY STEREOTACTIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 19020514

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization