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 03/18/2019

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

I have uploaded two hips to review for dr.(b)(6) at (b)(6) in the shared file under the folder titled "(b)(6), (b)(6) 2019 hip files." dr.(b)(6) wants her cup's version to be reviewed.Dr.(b)(6) liked the inclination on both hips but believes her version is off by about 10 degrees.I have intra-op and post-op x-rays that i can share with you as well.Thank you so much! case type: no associated procedure (tha).

Manufacturer Narrative

Reported event: an event regarding inaccurate cup placement involving 3.0 rio robotic arm - mics, catalog: 209999 was reported.Method & results: device history review: a review of the dhr associated with rio 645 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 cup placement discrepancy.There were 21 other reported events (b)(4).Conclusion: no system malfunction was confirmed.User errors in selecting landmarks and failing to lower the mako during robot registration may have contributed small errors to the inclination and version values.Patient landmarks used by the surgeon intraoperatively to determine inclination and version should match as closely as possible those landmarks selected in the mako system, which determines the cup inclination and version.

Event Description

I have uploaded two hips to review for dr.(b)(6) at (b)(6) in the shared file under the folder titled "(b)(6) (b)(6) 2019 hip files." dr.(b)(6) wants her cup's version to be reviewed.Dr.(b)(6) liked the inclination on both hips but believers her version is off by about 10 degrees.I have intra-op and post-op x-rays that i can share with you as well.Thank you so much! case type: no associated procedure (tha).

• 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: 8478217
• MDR Text Key: 141381458
• Report Number: 3005985723-2019-00269
• 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

• 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
• Initial Date Manufacturer Received: 03/18/2019
• Initial Date FDA Received: 04/03/2019
• Supplement Dates Manufacturer Received: 06/30/2019
• Supplement Dates FDA Received: 07/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization