BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.0 RIO® ROBOTIC ARM - MICS

    MDR report key: 8354694 · Received February 20, 2019

    Report

    Report Number
    3005985723-2019-00161
    Event Type
    Injury
    Date Received
    February 20, 2019
    Date of Event
    February 8, 2019
    Report Date
    April 23, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: AN EVENT REGARDING TIBIAL RESECTION DEEP INVOLVING 3.0 RIO ROBOTIC ARM - MICS, CATALOG: 209999 WAS REPORTED. METHOD & RESULTS: DEVICE HISTORY REVIEW: A REVIEW OF THE DHR ASSOCIATED WITH RIO 385 FOUND QUALITY INSPECTION PROCEDURES SUCCESSFULLY PASSED. COMPLAINT HISTORY: BASED ON THE DEVICE IDENTIFICATION (PN 209999) THE COMPLAINT DATABASES WERE REVIEWED FROM 2011 TO PRESENT FOR SIMILAR REPORTED EVENTS REGARDING TIBIAL RESECTION DEEP. THERE WERE TWO OTHER REPORTED EVENT FOR THE LISTED CATALOG NUMBER (PR1736005 AND PR178076). CONCLUSION: A REVIEW OF THE CASE LOGS SHOWED SEVERAL POSSIBLE CAUSES TO THE INACCURATE RESECTION. FIRSTLY SEVERAL RIO REGISTRATIONS WERE REQUIRED BEFORE THE MPS COULD GET ONE THAT PASSED. THIS WOULD IMPLY THAT ACCURACY ON EITHER THE ROBOT OR THE CUTTING TOOL WAS LESS THAN IDEAL. IN ADDITION WHEN ARM ACCURACY WAS PERFORMED IT FAILED THE FIRST TIME, IT PASSED THE SECOND TIME BUT WAS ONLY .003MM BELOW THE FAILURE THRESHOLD. THIS WOULD FURTHER IMPLY THAT ROBOT ACCURACY WAS NOT PROPERLY CALIBRATED. SECONDLY DURING BONE PREPARATION THERE WERE BOTH KNEE TRACKER AND BASE TRACKER VELOCITY TRAPS WHICH WERE LOGGED. THE COMBINATION OF THESE ISSUE ARE LIKELY THE CAUSE OF THE INACCURATELY DEEP CUTS.

    Description of Event or Problem · 0

    AFTER PASSING FEMUR AND CUTTER CHECKPOINT, SURGEON NOTICED BURR WAS BURRING MUCH DEEPER THAN PLANNED. CAN PROVIDE FULL DETAIL ON EVENT ASAP. CASE TYPE: PKA. SURGICAL DELAY: 30 MINUTES. UPDATE PER MPS: THE PLAN WAS TO CONDUCT A PRIMARY PKA BUT BURRING WAS MUCH DEEPER THAN PLANNED AND A TKA WAS IMPLANTED INSTEAD OF THE PKA. THE SURGEON DID NOT HAVE ANY ISSUES WITH THE BURRING DEVICE OR THE ANSPACH MOTOR. (SEE ATTACHED EMAIL FOR FURTHER DETAILS).

    Additional Manufacturer Narrative · 1

    AS PART OF THE 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

    AFTER PASSING FEMUR AND CUTTER CHECKPOINT, SURGEON NOTICED BURR WAS BURRING MUCH DEEPER THAN PLANNED. CAN PROVIDE FULL DETAIL ON EVENT ASAP. CASE TYPE: PKA. SURGICAL DELAY: 30 MINUTES. UPDATE PER MPS: THE PLAN WAS TO CONDUCT A PRIMARY PKA BUT BURRING WAS MUCH DEEPER THAN PLANNED AND A TKA WAS IMPLANTED INSTEAD OF THE PKA. THE SURGEON DID NOT HAVE ANY ISSUES WITH THE BURRING DEVICE OR THE ANSPACH MOTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149258 3.0 RIO® ROBOTIC ARM - MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other