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 02/04/2019

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

Event description: dr.(b)(6) hips are going in at incorrect version and inclination.I have uploaded two hips from 2-4-19 to the shared drive under the file ¿flint 2-4-19 hips.¿ i have post op xrays i can share as well.Thank you.This pi is being created to report the 2nd to 2 cases performed under the same robot, on the same day.Patient identifier l, see pi 2006753 referencing the complaint 1 of 2.Case type: tha.What is the estimated discrepancy mentioned in the complaint? tha (degrees) according to the patients post-op x-rays, it shows lee around 15 degrees off and vanveelen around 10 degrees off.

Manufacturer Narrative

Follow-up #1 and final report submitted based on the results of investigation.Reported event: an event regarding inaccurate cup placement involving 3.0 rio robotic arm - mics, catalog: 209999 was reported.Method & results: device history review: a review of the dhr associated with rio 645 found quality inspection procedures successfully passed.Complaint history: based on the device identification ((b)(4)) the complaint databases were reviewed from 2011 to present for similar reported events regarding cup placement discrepancy.There were 21 other reported events ((b)(4)).Conclusion: there is no system malfunction detected.The surgeon did not pick their patient and ct landmarks in the same location.This leads to error in registration, which leads to the system calculating an incorrect inclination and version.The system behaved as intended.

Event Description

Event description: dr.(b)(6) hips are going in at incorrect version and inclination.I have uploaded two hips from (b)(6) 2019 to the shared drive under the file ¿flint (b)(6) 2019 hips.¿ i have post op xrays i can share as well.Thank you.This pi is being created to report the 2nd to 2 cases performed under the same robot, on the same day.Patient identifier l, see pi (b)(6) referencing the complaint 1 of 2.Case type: tha.What is the estimated discrepancy mentioned in the complaint? tha (degrees) according to the patients post-op x-rays, it shows (b)(6) around 15 degrees off and (b)(6) around 10 degrees off.

• 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: 8386491
• MDR Text Key: 137836865
• Report Number: 3005985723-2019-00190
• 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: 07/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2019
• 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: 07/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 85 YR