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 01/23/2019

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

This pi is for the robot used in the procedure.Primary procedure, mako tka.It was reported that all cuts were made as per plan.Cuts visually looked good.When the femoral component was trialed, the trial did not sit flush.Both the anterior chamfer and the distal condyle had a 2-3mm gap.The cuts were re-done with the same result.The trial was moved proximal by.5mm to do more bony cuts, and still a gap existed.Surgeon decided to cement in the femoral components with the gaps as they were.A surgical delay of 80 minutes without use of tourniquet was reported.Patient's bone quality was reported as very hard/ dense.

Manufacturer Narrative

Follow-up #1 and final report submitted.Reported event: an event regarding inaccurate resection 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 the rio from the reported event could not be completed because the robot serial number was not reported.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.There was one other reported event for the listed catalog number (pr 1537088, pr1419895, pr1427242, pr1440996, pr1407370, pr1419895, pr1427242, pr1433496, pr1443555, pr 1449671, pr1516994, pr1528344, pr 1549560, pr 1748126, pr 1765984, pr 1757777, pr 1748590, pr1910116, pr1910115, pr1973447 and pr1940380).Conclusion: product inspection could not be completed because log files and session files were not provided after three communications to the mps.Product was not available for evaluation.

Event Description

This pi is for the robot used in the procedure.Primary procedure, mako tka.It was reported that all cuts were made as per plan.Cuts visually looked good.When the femoral component was trialed, the trial did not sit flush.Both the anterior chamfer and the distal condyle had a 2-3mm gap.The cuts were re-done with the same result.The trial was moved proximal by.5mm to do more bony cuts, and still a gap existed.Surgeon decided to cement in the femoral components with the gaps as they were.A surgical delay of 80 minutes without use of tourniquet was reported.Patient's bone quality was reported as very hard/dense.

• 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: 8309895
• MDR Text Key: 136030331
• Report Number: 3005985723-2019-00099
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2019
• 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: 03/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 58 YR