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 02/25/2019

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

After all cuts were made robotically, cuts were not accurate enough to press fit the femur.Distal cut was passed over twice, as it is done on each mako case.All green was resected and no cuts were deep on the mako guidance module monitor, however, there were gaps present when trialing.Cement was needed to place the final implant and dr was very upset and said that he can do better manually.16-30 minutes surgical delay.Case type: tka.What is the estimated discrepancy based on the plan, mentioned in the complaint? as per the mps: in general, there were gaps when placing the implant.Most prominent was the anterior chamfer.Distal cut was successfully cut to plan and posterior cuts were not made deep.

Event Description

After all cuts were made robotically, cuts were not accurate enough to press fit the femur.Distal cut was passed over twice, as it is done on each mako case.All green was resected and no cuts were deep on the mako guidance module monitor, however, there were gaps present when trialing.Cement was needed to place the final implant and dr was very upset and said that he can do better manually.16-30 minutes surgical delay case type: tka.What is the estimated discrepancy based on the plan, mentioned in the complaint? as per the mps: in general, there were gaps when placing the implant.Most prominent was the anterior chamfer.Distal cut was successfully cut to plan and posterior cuts were not made deep.

Manufacturer Narrative

Follow-up #1 and final report submitted to update sections d.3, g.1, g.4, g.7, h.2, h.3, h.6, h.10 and h.11 based on the results of investigation.Reported event: an event regarding inaccurate resection and poor trial fit during a total knee procedure involving 3.0 rio robotic arm - mics, catalog: 209999 was reported.Method & results: -device history review: a review of the dhr associated with rio 588 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 inaccurate resection and poor trial fit during a tka procedure.There was one other reported event for the listed catalog number ((b)(4)).-conclusion: the case files (patient session data and vplog data) were reviewed.An analysis of the application workflow, femur checkpoint values, femur registration values, rio registration and verification values, bone preparation checkpoints, burrlist and implant plan was completed.A comparison of the burrlist and the patient implant plan shows that the femoral resections were made according to the plan.All other areas of the investigation found error values within the accuracy tolerance region.No system defect or malfunction is suspected.

• 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: 8392078
• MDR Text Key: 138141476
• Report Number: 3005985723-2019-00206
• 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: 03/05/2019
• 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: 06/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization