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

Model Number 209999

Device Problems Imprecision (1307); Output Problem (3005)

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

Event Date 07/29/2019

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

During the surgical procedure we noticed that the anterior chamfer cut looked proud.We checked the cut with our green probe and had a reading of 1.8mm proud on both the medial and lateral aspects of the anterior chamfer cut.We then went back over the cut and checked again.The cut was still approximately 0.9mm proud on the medial aspect of the cut and 1.2mm proud on the lateral aspect.We then cut again and took it down to 0.0mm on the medial side and 0.2mm on the lateral side.The visual on the screen had turned ¿white¿ indicating the bone was cleared even though we still had 1.8mm of bone remaining.This surgeon has filed 8 other complaints with the same issue; in the past this has caused malpositioning of the component & inability to pressfit.With this case our outcome was fine, but we are requesting an expedited look into this particular consistent issue.Please associate this case with all the other cases as (b)(6) are having a meeting with dr (b)(6) this week to discuss.Case type: tka.Surgical delay: = 15 minutes.

Manufacturer Narrative

An event regarding inaccurate resection involving 3.0 rio® robotic arm - mics, catalog: 209999 was reported.It was reported, ¿during the surgical procedure we noticed that the anterior chamfer cut looked proud.We checked the cut with our green probe and had a reading of 1.8mm proud on both the medial and lateral aspects of the anterior chamfer cut.We then went back over the cut and checked again.The cut was still approximately 0.9mm proud on the medial aspect of the cut and 1.2mm proud on the lateral aspect.We then cut again and took it down to 0.0mm on the medial side and 0.2mm on the lateral side.The visual on the screen had turned ¿white¿ indicating the bone was cleared even though we still had 1.8mm of bone remaining.This surgeon has filed 8 other complaints with the same issue; in the past this has caused malpositioning of the component & inability to pressfit.With this case our outcome was fine, but we are requesting an expedited look into this particular consistent issue.Please associate this case with all the other cases as chris (b)(6) are having a meeting with dr (b)(6) this week to discuss¿.Product evaluation and results: not performed as case session data was not provided after 3 requests for additional information.Product history review: review of the device history records associated with rio 234 indicate quality inspection procedures were completed with no reported discrepancies.Complaint history review: a search of the complaint database under device identification pn 209999 reports similar complaints for tka software - inaccurate resection.Conclusions: the failure could not be determined as no case session data or logs were provided after three communication attempts were made.Without the case files the operation set up, bone registration and bone preparation could not be assessed.No additional investigation or specific actions are required at this time.If additional information is received such as the session files, then the complaint will be reopened.

Event Description

During the surgical procedure we noticed that the anterior chamfer cut looked proud.We checked the cut with our green probe and had a reading of 1.8mm proud on both the medial and lateral aspects of the anterior chamfer cut.We then went back over the cut and checked again.The cut was still approximately 0.9mm proud on the medial aspect of the cut and 1.2mm proud on the lateral aspect.We then cut again and took it down to 0.0mm on the medial side and 0.2mm on the lateral side.The visual on the screen had turned ¿white¿ indicating the bone was cleared even though we still had 1.8mm of bone remaining.This surgeon has filed 8 other complaints with the same issue; in the past this has caused malpositioning of the component & inability to pressfit.With this case our outcome was fine, but we are requesting an expedited look into this particular consistent issue.Please associate this case with all the other cases as (b)(6) are having a meeting with dr (b)(6) this week to discuss.Case type: tka.Surgical delay: =15 minutes.

• 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: 8918044
• MDR Text Key: 155409278
• Report Number: 3005985723-2019-00598
• 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: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 209999
• Device Catalogue Number: 209999
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization