MAUDE Adverse Event Report: MAKO SURGICAL CORP. 3.0 RIO® ROBOTICARM - MICS; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	209999
Medical Device Problem Codes	Application Program Problem: Parameter Calculation Error (1449); Incorrect, Inadequate or Imprecise Result or Readings (1535); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
While placing the tibial trial, the surgeon made a comment about the baseplate not sitting on the medial cortical rim.That it was pushed lateral towards the eminence considerably.The tibial checkpoint gave a value of 3.8mm, walked the bone and realized we had a bumped array.Pka 3.0.
Additional Manufacturer Narrative
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
Reported event.An event regarding inaccurate resection involving a mako pka software was reported.The event was confirmed.Method & results.-product evaluation and results: review of the case session files noted the following: not all pre-surgery checks were completed.All pre-surgery checks must be completed to verify that the robot is performing within its specifications.The excessive velocity limit warnings in frequency and magnitude during pre-surgery checks indicate either an unstable base array or rough use of the robotic arm.In addition, there were velocity trap warnings during the tibial bone resection which may indicate: ¿ unstable joint or leg holder; ¿ rough handling of the robotic arm; ¿ unstable base or bone array.1.Quality of tibial registration: the tibial shaft rotational bone registration points locking in the tibial internal-external rotation were not taken.Best surgical practice is to always capture these tibial shaft rotational bone registration points for high quality bone registration.2.Checkpoint cutter and bone: a failed tibia bone checkpoint following the tibial resection indicates a movement of either the checkpoint or the bone tracker resulting in the loss of bone registration.The loss of bone registration during the medial wall resection is responsible for the mismatch between the planned and actual tibial baseplate implant location.For other passing checkpoint values please see table below and the workflow section.There is no indication that mako system was performing outside of its specifications.-clinician review: no medical records were received for review with a clinical consultant.-product history review: a review of device history records shows that was inspected and the quality inspection procedures were completed with no reported discrepancies -complaint history review: a review of complaints in trackwise related to p/n 209999, robot number: shows other similar complaints for robotic arm - inaccurate resection.Conclusions: based on the analysis of the session files noted " not all pre-surgery checks were completed.All pre-surgery checks must be completed to verify that the robot is performing within its specifications.The excessive velocity limit warnings in frequency and magnitude during pre-surgery checks indicate either an unstable base array or rough use of the robotic arm.A failed tibia bone checkpoint following the tibial resection indicates a movement of either the checkpoint or the bone tracker resulting in the loss of bone registration.The loss of bone registration during the medial wall resection is responsible for the mismatch between the planned and actual tibial baseplate implant location.There is no indication that mako system was performing outside of its specifications.".Thus, the alleged failure mode is confirmed to be potentially caused by user error.No additional investigation or specific actions are required.If additional information is received, then the complaint will be reopened.
Event or Problem Description
While placing the tibial trial, the surgeon made a comment about the baseplate not sitting on the medial cortical rim.That it was pushed lateral towards the eminence considerably.The tibial checkpoint gave a value of ~3.8mm, walked the bone and realized we had a bumped array.Pka 3.0.

• Brand Name: 3.0 RIO® ROBOTICARM - MICS
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 3365 enterprise ave; weston FL 33331
• Manufacturer (Section G): MAKO SURGICAL CORP.; 3365 enterprise ave; weston FL 33331
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17836252
• Report Number: 3005985723-2023-00149
• Device Sequence Number: 12686542
• Product Code: OLO
• UDI-Device Identifier: 00848486030407
• UDI-Public: 00848486030407
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 209999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/06/2023
• Supplement Date Received by Manufacturer: 11/01/2023
• Initial Report FDA Received Date: 09/28/2023
• Supplement Report FDA Received Date: 11/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown