BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PELVIC ARRAY ASSY

    MDR report key: 6343416 · Received February 20, 2017

    Report

    Report Number
    3005985723-2017-00083
    Event Type
    Malfunction
    Date Received
    February 20, 2017
    Date of Event
    February 9, 2017
    Report Date
    March 15, 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# 19030315 WHICH HAD A DAMAGED SCREW. DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION: VISUAL INSPECTION OF THE ARRAY SHOWS THAT THE SCREW HAS DAMAGE TO THE THREADS. 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 THREADS BEING DAMAGED RENDERS THE ASSEMBLY DIFFICULT TO USE. DEVICE HISTORY REVIEW: A REVIEW OF THE DEVICE HISTORY RECORDS SHOWS THAT (B)(4) PARTS WERE RECEIVED, INSPECTED AND ACCEPTED INTO STOCK ON JUNE 16, 2016 WITH NO FAILURES. COMPLAINT HISTORY REVIEW: BASED ON THE DEVICE IDENTIFICATION, P/N 112240, LOT #19030315, THE COMPLAINT DATABASES WERE REVIEWED FROM 2011 TO PRESENT FOR SIMILAR REPORTED EVENTS REGARDING THREAD DAMAGE. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT NUMBER REFERENCED, HOWEVER, THERE ARE 2 EVENTS FOR THE PART: TRACKWISE # (B)(4). CONCLUSIONS: THE FAILURE MODE OF A DAMAGED SCREW ON A PELVIC ARRAY ASSEMBLY WAS CONFIRMED. THE ROOT CAUSE OF THE FAILURE IS ATTRIBUTED TO CROSS THREADING. THE FAILURE OCCURRED PRE-OP, 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 HIP ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM. THE PELVIC ARRAY AND CLAMP ADAPTER THREADS WERE CROSS THREADED TOGETHER. CROSS THREADING MUST HAVE HAPPENED AS THE SURGEON PLACED THE ARRAY ON INITIALLY. HE WAS HAVING A HARD TIME PUTTING IT ON BUT WAS ABLE TO SECURE IT. MPS NOTICED THAT THE THREADS WERE DAMAGED AS THEY DISASSEMBLED AND PUT THE PARTS BACK IN THE TRAYS

    Description of Event or Problem · 1

    THE SURGEON WAS COMPLETING A TOTAL HIP ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM. THE PELVIC ARRAY AND CLAMP ADAPTER THREADS WERE CROSS THREADED TOGETHER. CROSS THREADING MUST HAVE HAPPENED AS THE SURGEON PLACED THE ARRAY ON INITIALLY. HE WAS HAVING A HARD TIME PUTTING IT ON BUT WAS ABLE TO SECURE IT. MPS NOTICED THAT THE THREADS WERE DAMAGED AS THEY DISASSEMBLED AND PUT THE PARTS BACK IN THE TRAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125955 PELVIC ARRAY ASSY STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 19030315

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization