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

Model Number 209999

Device Problem Positioning Failure (1158)

Patient Problems Bone Fracture(s) (1870); Hip Fracture (2349)

Event Date 02/03/2020

Event Type  Injury  

Manufacturer Narrative

As part of normal complaint follow-up, an evaluation of the event has been initiated by mako surgical.A supplement al report will be submitted when additional information becomes available.

Event Description

Case was planned, doctor confirmed plan.Case was completed fully with only minor issues during reaming.Cup was impacted to 2 deep.Postoperative x-ray shows cup went through the medial wall.Logs and plan attached in complaints folder.Case type: tha.

Manufacturer Narrative

Reported event: an event regarding ¿case was planned, doctor confirmed plan.Case was completed fully with only minor issues during reaming.Cup was impacted to 2 deep.Postoperative x-ray shows cup went through the medial wall.Logs and plan attached in complaints folder.Case type: tha¿.Product evaluation and results: review of the log/session files has not been completed within 90days of the complaint being opened.The complaint will be closed with an associated risk assessment.Additional failures will be assessed once the log/session file review has been completed.The intraoperative fracture was confirmed by the supplied x-ray and video but a system related failure cannot be confirmed without reviewing the log/session files.Product history review: a review of device history records shows that rob933 was inspected on 05 june 2019 and the quality inspection procedures were completed with no reported discrepancies.Complaint history review: a search of the complaint database under device identification pn 219999, rob933 reports no similar complaints for tha software - inaccurate resection conclusions: the exact cause of the event could not be determined because insufficient information was made available for evaluation.Review of the log/session files has not been completed within 90days of the complaint being opened.A review of the case session/log data is needed to complete a full investigation for determining root cause.In addition to a review of the log/session, a field service engineer conducts scheduled maintenance on the robot to ensure the robot is system ready.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.

Event Description

Case was planned, doctor confirmed plan.Case was completed fully with only minor issues during reaming.Cup was impacted to 2 deep.Postoperative x-ray shows cup went through the medial wall.Logs and plan attached in complaints folder.Case type: 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: 9764967
• MDR Text Key: 181395343
• Report Number: 3005985723-2020-00115
• 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: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 209999
• Device Catalogue Number: 209999
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other