BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIO SURGICAL ARM

    MDR report key: 6185101 · Received December 19, 2016

    Report

    Report Number
    3005985723-2016-00442
    Event Type
    Malfunction
    Date Received
    December 19, 2016
    Date of Event
    December 14, 2016
    Report Date
    January 31, 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

    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 WAS CONFIRMED TO BE A J6 ARM FOR HIP WITH QD, P/N 207557, LOT RO287. DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATES ROB287, WHICH INCLUDES THE J6 SEGMENT, WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK ON 06/23/2014. DEVICE EVALUATION AND RESULTS: ACCORDING TO GSP CASE (B)(4), THE FSE DETERMINED THAT THE J6 ENCODER HAD DELAMINATED FROM THE HUB. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS RELATED TO THE J6 ARM SHOWS 10 ADDITIONAL COMPLAINTS SINCE JANUARY 2015 RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSIONS: THE FAILURE WAS CONFIRMED BY THE FSE. CORRECTIVE ACTION/PREVENTIVE ACTION: NO ACTION IS REQUIRED AT THIS TIME AS THERE IS NO INDICATION TO SUGGEST A PRODUCT NON-CONFORMITY OR UNANTICIPATED HAZARD.

    Description of Event or Problem · 1

    THE SURGEON WAS COMPLETING A TOTAL HIP ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) WHEN AN ENCODER ERROR OCCURRED. THE SURGEON WAS ABLE TO FINISH THE CASE MANUALLY.

    Description of Event or Problem · 1

    THE SURGEON WAS COMPLETING A TOTAL HIP ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) WHEN AN ENCODER ERROR OCCURRED. THE SURGEON WAS ABLE TO FINISH THE CASE MANUALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837974 RIO SURGICAL ARM STEREOTACTIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization