BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PELVIC ARRAY ADAPTOR ASSY

    MDR report key: 6074099 · Received November 2, 2016

    Report

    Report Number
    3005985723-2016-00349
    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

    REPORTED EVENT: THE REPORTED DEVICE WAS A PELVIC ARRAY ADAPTOR ASSY, CATALOG# 112240, LOT # 19070212 THAT WAS CROSS THREADING WITH A MATING COMPONENT. DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION: VISUAL INSPECTION SHOWS THAT THERE IS A DENT IN THE FIRST THREAD ON ONE SIDE OF THE PART THAT HAS THE TWO INTERNAL THREADS. SEE ATTACHED PICTURE. THE DENT IS CONSISTENT WITH A SHARP METAL OBJECT STRIKING THE THREAD WITH A LOT OF FORCE. THIS COULD BE FROM THE ADAPTOR FALLING ON ANOTHER INSTRUMENT; OR ANOTHER INSTRUMENT FALLING ON IT. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION WAS NOT COMPLETED AS THE VISUAL INSPECTION WAS SUFFICIENT TO CONFIRM THE FAILURE MODE. FUNCTIONAL INSPECTION: THE DAMAGED INTERNAL THREAD ON THE ADAPTOR WAS NOT ABLE TO ACCEPT A SCREW FROM A MATING PART CONFIRMING THE FAILURE MODE MADE IN THE COMPLAINT. DEVICE HISTORY REVIEW: A REVIEW OF THE DEVICE HISTORY RECORDS SHOWS THAT (B)(4) PARTS WERE RECEIVED, INSPECTED AND ACCEPTED INTO FINAL STOCK ON MAY 22, 2012 WITH NO FAILURES. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS RELATED TO P/N 112240, LOT #19070212 SHOWS NO ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. A SEARCH FOR THE P/N SHOWS 8 ADDITIONAL COMPLAINTS. THEY ARE TRACKWISE COMPLAINT #'S (B)(4). CONCLUSIONS: THE FAILURE MODE OF A CROSS THREADING 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

    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
    725102 PELVIC ARRAY ADAPTOR ASSY STEREOTACTIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. LOT #(S): 19070212

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization