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

Catalog Number 209999

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

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

Event Date 10/25/2016

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

The surgeon was completing a partial knee arthroplasty procedure using the robotic arm interactive orthopedic system (rio) when the system displayed a hardware error #11.After failed attempts to resolve the issue, the surgeon had to complete the case manually.The case was delayed by approximately 10 minutes.

Manufacturer Narrative

Reported event: the reported device is a 3.0 rio® robotic arm - mics, catalog: 209999 which returned an error code 11 - j2 hall error.Device evaluation and results: the inspection of the device was documented per gsp case # 137950 as shown below: "error code 11 - hall error j2.Replaced j2 hall wire (201402) and all post testing passed.System is ready for clinical use." device history review: a review of the dhr associated with rob 215 found qips passed with no notes or comments and final signature added august 2, 2012.Complaint history review: based on the device identification (pn 209999) the complaint databases were reviewed from 2011 to present for similar reported events regarding rob215 getting hall errors for joint 2.There were no other reported events for the listed serial number.Conclusions: the reported failure of a j2 hall error was confirmed during the filed repair.The issue occurred.

Event Description

The surgeon was completing a partial knee arthroplasty procedure using the robotic arm interactive orthopedic system (rio) when the system displayed a hardware error #11.After failed attempts to resolve the issue, the surgeon had to complete the case manually.The case was delayed by approximately 10 minutes.

• Brand Name: 3.0 RIO® ROBOTIC ARM - MICS
• Type of Device: STEREOTACTIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer (Section G): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer Contact: liza gordillo ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 6078660
• MDR Text Key: 59221011
• Report Number: 3005985723-2016-00361
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112507
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 209999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization