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

Catalog Number 209999

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 11/03/2016

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 total hip arthroplasty procedure using the robotic arm interactive orthopedic system (rio) when a hall error occurred.The surgeon had to complete the case manually.

Manufacturer Narrative

Follow-up #1 and final report submitted to update sections based on the results of investigation.Reported event: the reported device is a 3.0 rio® robotic arm - mics, catalog: 209999, serial#: (b)(4) could not move over entire range and j5 hall error occured.Device history: a review of the dhr associated with rio 118 found the pt review successfully passed, all associated npr's have been closed.Device evaluation: according to gsp case #(b)(4), "mps tom pratt reported j1 not moving over full range.Cable wrap was secured to free up j1.System successfully passed pre-surgery checks.Verified system is operating within mako tolerances and specifications.Attached all supporting documentation.System is ready for clinical use." in addition: mps (b)(6) reported hall error.Intermittent issue was resolved by replacing the cpci backside card pn 208606-1 and the j5 hall wire.System successfully passed all validation testing.Verified system is operating within mako tolerances and specifications.Attached all supporting documentation.System is ready for clinical use.Complaint history: based on the device identification (pn 209999) the complaint databases were reviewed from 2011 to present for similar reported events regarding j1 not moving over full range.There were no other reported events for the serial number referenced.Conclusion: a j5 hall error occured during a procedure preventing the surgeon from continuing.In addition it was noted that j1 could not move at its full range of motion.Upon servicing a cable wrap was secured to free j1 and the cpci card as well as the hall wire were replaced to fix the j5 hall error.The system passed all pre surgery checks and is ready for clinical use.Further action: none at this time.

Event Description

The surgeon was completing a total hip arthroplasty procedure using the robotic arm interactive orthopedic system (rio) when a hall error occurred.The surgeon had to complete the case manually.

• 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: 6141595
• MDR Text Key: 61356305
• Report Number: 3005985723-2016-00410
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141989
• 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: 01/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2016
• 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?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/03/2017
• 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