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 05/23/2019

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

Mps reported surgeon is expressing serious concerns with this robot.Surgeon will not perform more cases until the system has been checked after extreme anterior notching in last case.Case number (b)(4).Update: "it was a right tka with about an hour delay because we had to put a a stem in.

Event Description

Mps reported surgeon is expressing serious concerns with this robot.Surgeon will not perform more cases until the system has been checked after extreme anterior notching in last case.Case number (b)(4).Update: "it was a right tka with about an hour delay because we had to put a stem in.".

Manufacturer Narrative

Follow-up #1 and final report submitted based on the results of investigation.Reported event: an event regarding anterior femoral notching during a knee procedure to 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 561 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 notching.There were other reported events for the listed catalog number (pr1848273, 1736744, 1730336, pr1443555, pr1574869, pr1597920, pr1636892, pr1694868, pr1689895, pr1848273, pr1920082, pr2094697, and pr1951314).Conclusion: per wo-(b)(4): "on (b)(6) 2019 - per email - (b)(6) ¿ call cancelled, customer does not want service at this time." per pr2094697, opened to address the initial notching event: "the case files (patient session data and vplog data) were reviewed.An analysis of the 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: 8681143
• MDR Text Key: 147885610
• Report Number: 3005985723-2019-00417
• 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: 08/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2019
• 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?: No
• Date Manufacturer Received: 08/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization