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

Model Number 209999

Device Problems Positioning Failure (1158); Inaccurate Delivery (2339)

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

Event Date 11/26/2019

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

Case number: 04419115, (b)(4) - mps (b)(6) reported inaccurate anterior chamfer cuts.Case type: tka.Update: "any surgical delay? less than 15.Which cuts were inaccurate? anterior chamfer.How was the cut inaccurate? 1.5-2 mm proud.What is the estimated discrepancy mentioned in the complaint? 1.5-2 mm proud on anterior chamfer cut.Issue was fixed when robot was brought back in, without adjusting plan and went over cut again.When was the issue noticed (bone preparation or joint assessment)? trialing.Was the planar probe utilized to measure cut accuracy? no.Are post-op x-rays available? no.".

Manufacturer Narrative

Reported event: (b)(6) - mps reported inaccurate anterior chamfer cuts.Device evaluation and results: the field service engineer reported: problem reproduced? no.Trouble shooting notes: bryant called after case and already spoke to fse.Requesting wo.Work performed: upon arrival at site i initially performed a successful pre-surgery check.I also performed an auto-arm accuracy test without any indication of error.I checked j2 to verify that the calibration was correct.It was spot on.Both the 10 and 32 degree settings were dead on.I continued to run the system through other checks and everything is exactly as it should be.System is ready for clinical use.I contacted mps and let him know my findings.I suggested that he perhaps run the problems they've been having up the chain to see if perhaps he may be able to find an answer to the issues they're experiencing.The robot is not the issue though.Work order disposition: system investigation completed successfully as per service manual.All system checks and tests passed, system is ready for use.Product history review: a review of device history records shows that on 06/20/19 1 device was inspected and 1 device was placed on.A review of the data revealed that the non-conformances are not related to the failure alleged in this compliant.Complaint history review : a review of complaints in catsweb and trackwise related to p/n 207557, serial number (b)(6) shows no additional complaints related to the failure in this investigation.Conclusions: the failure was not confirmed via inspection.No additional investigation or specific actions are required.If additional information is received, then the complaint will be reopened.H3 other text : device not returned.

Event Description

Case number: (b)(4), (b)(6) - mps (b)(6) reported inaccurate anterior chamfer cuts.Case type: tka.Update: "any surgical delay? less than 15.Which cuts were inaccurate? anterior chamfer.How was the cut inaccurate? 1.5-2 mm proud.What is the estimated discrepancy mentioned in the complaint? 1.5-2 mm proud on anterior chamfer cut.Issue was fixed when robot was brought back in, without adjusting plan and went over cut again.When was the issue noticed (bone preparation or joint assessment)? trialing.Was the planar probe utilized to measure cut accuracy? no.Are post-op x-rays available? no".

• 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: 9511076
• MDR Text Key: 175278702
• Report Number: 3005985723-2019-00915
• 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: 05/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• 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: 05/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 79