MAUDE Adverse Event Report: MAKO SURGICAL CORP. 3.0 RIO® ROBOTIC ARM - MICS; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number 209999

Device Problems Computer Software Problem (1112); Output Problem (3005)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/26/2018

Event Type  malfunction  

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.

Event Description

Tha.Event description: dr.(b)(6) has been stating that some of her cups look more vertical than what was planned them during her tha procedures.I am going to upload two different hip cases in the shared folder named "mclaren flint tha cases" so that you can review the cup placement.One of these cases was done by me and the other was done by a senior mps on my team.We would love any feedback regarding the placement of her cups.Please let me know if i uploaded the case files correctly.

Manufacturer Narrative

Follow-up #1 and final report submitted.Reported event: an event regarding incorrect landmark selected involving 3.0 rio robotic arm - mics, catalog: 209999 was reported.Method & results: device history review: a review of the dhr associated with rio found quality inspection procedures successfully passed.Complaint history: a search of the complaint database under device identification pn: 209999 reports similar complaints for tha software - incorrect landmark selected.The complaint record numbers are: (b)(4).Conclusion: a review of the session data for this plan shows there was a large discrepancy between where patient landmarks were selected and where ct landmarks were selected.This error would cause a rotation to occur during registration affecting accuracy.The only version and inclination value available were the ones provided during impaction surgical results page was not executed.Without the version and inclination value from this page its not possible to confirm whether there was error in the version and inclination of the cup.The mismatch between ct landmarks and patient landmarks could have caused the issue reported by the surgeon.Per the data in the logs the system appears to have behaved as expected and accuracy of registration and landmark selection is the cause of error.Note: both plans provided by mps showed discrepancies between the ct and patient landmarks primarily the superior and anterior landmarks.

Event Description

Tha.Event description: dr.(b)(6) has been stating that some of her cups look more vertical than what was planned them during her tha procedures.I am going to upload two different hip cases in the shared folder named "(b)(6) tha cases" so that you can review the cup placement.One of these cases was done by me and the other was done by a senior mps on my team.We would love any feedback regarding the placement of her cups.Please let me know if i uploaded the case files correctly.

• Brand Name: 3.0 RIO® ROBOTIC ARM - MICS
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8263512
• MDR Text Key: 133856981
• Report Number: 3005985723-2019-00068
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486030407
• UDI-Public: 00848486030407
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 209999
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization