BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PELVIC ARRAY ASSY

    MDR report key: 6074205 · Received November 2, 2016

    Report

    Report Number
    3005985723-2016-00350
    Event Type
    Malfunction
    Date Received
    November 2, 2016
    Date of Event
    October 27, 2016
    Report Date
    December 20, 2016
    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

    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.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT: THE REPORTED DEVICE IS A PELVIC ARRAY ASSY, CATALOG# 112230, LOT# 19030312 WHICH WAS CROSS THREADING WITH THE MATING PART. DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION: VISUAL INSPECTION OF THE SCREW THREADS SHOWS THAT THE FIRST THREAD ON THE SCREW IS DAMAGED AND FLATTENED ONTO THE MINOR DIAMETER. SEE ATTACHED PICTURE. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION WAS NOT COMPLETED AS THE VISUAL INSPECTION WAS SUFFICIENT TO CONFIRM THE FAILURE MODE. FUNCTIONAL INSPECTION: THE ARRAY SCREW COULD NOT BE THREADED INTO THE MATING THREADS OF A 112240 PELVIC ARRAY ADAPTOR ASSEMBLY CONFIRMING THE FAILURE MODE. DEVICE HISTORY REVIEW: A REVIEW OF THE DEVICE HISTORY RECORDS SHOWS THAT (B)(4) PARTS WERE RECEIVED, INSPECTED AND REJECTED ON NPR 12-09-0007 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 CROSS THREADING. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT NUMBER REFERENCED, HOWEVER, THERE WERE 3 COMPLAINTS FOR OTHER LOT NUMBERS: TRACKWISE INVESTIGATIONS ARE (B)(4). CATSWEB COMPLAINT IS (B)(4). CONCLUSIONS: THE FAILURE MODE OF A DIFFICULT TO THREAD PELVIC ARRAY WAS CONFIRMED. THE FAILURE IS CONSISTENT WITH DAMAGE CAUSE WHEN AXIAL FORCE IS APPLIED TO THE SCREW BEFORE THE THREAD HAS ENGAGED PROPERLY. THE FAILURE WAS NOTICED DURING THE CASE BUT THERE WAS NO PATIENT INVOLVEMENT AND THE CASE WAS COMPLETED SUCCESSFULLY. CORRECTIVE ACTION/PREVENTIVE ACTION: NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    A SURGEON WAS PERFORMING A MAKOPLASTY TOTAL HIP ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO), WHEN CROSS THREADING OF INSTRUMENTS OCCURRED.

    Description of Event or Problem · 1

    A SURGEON WAS PERFORMING A MAKOPLASTY TOTAL HIP ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO), WHEN CROSS THREADING OF INSTRUMENTS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723419 PELVIC ARRAY ASSY STEREOTACTIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. LOT #(S): 19030312

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization