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 12/17/2018

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

Surgeon brought up post-op scans and the cup was placed incorrectly.(b)(6) was the mps in the surgery.Surgery was exported and put in complaints folder under ¿(b)(6) 2018_dr (b)(6)_(b)(6)¿.The surgery was on (b)(6).I was made aware of the post-op x-ray on 12/20.Case type: tha.

Event Description

Surgeon brought up post-op scans and the cup was placed incorrectly.(b)(6) was the mps in the surgery.Surgery was exported and put in complaints folder under (b)(4).The surgery was on (b)(6).I was made aware of the post-op x-ray on 12/20.Case type: tha.

Manufacturer Narrative

Reported event: an event regarding inaccurate cup version involving 3.0 rio robotic arm - mics, catalog: 209999 was reported.Method & results: device history review: a review of the dhr associated with rio 297 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 cup placement discrepancy.There were 18 other reported events (b)(4).Conclusion: the final registration includes the point cloud as well as the patient landmarks.The interplay between the patient landmarks and point cloud indicates that there are errors in both the patient landmark selection and in the point cloud which cause errors in inclination/version and in superior-inferior translations.This resulted in less medialization of the cup and errors in the actual inclination and version of the cup when compared to plan.The mako system performed within its specification.User failed to capture an accurate point cloud and patient landmarks leading to bone registration errors effecting cup placement both positionally and the inclination and version of the cup.

• 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: 8253150
• MDR Text Key: 133334558
• Report Number: 3005985723-2019-00060
• 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: 05/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2019
• 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: 04/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization