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

Catalog Number 209999

Device Problems Device Displays Incorrect Message (2591); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 08/30/2016

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 performing a partial knee arthroplasty using the robotic arm interactive orthopedic system (rio).During burring of bone the surgeon could not burr for longer than 1 to 2 seconds without the power shutting off and an error popping up.The case had approximately a 30 minute delay but was then completed successfully.

Manufacturer Narrative

Follow-up #1 and final report submitted to update mfr contact info, manufacturer site, date received by mfr, type of reports, if follow-up, what type?, device evaluated by mfr?, evaluation codes, additional mfr narrative based on the results of investigation.Reported event: an event regarding intermittent burr shut off and blocked array messages involving 3.0 rio robotic arm - mics, catalog: 209999 was reported.Method & results: -device history review: a review of the dhr associated with rio 281 found quality inspection procedures successfully passed.-complaint history: a review of complaints related to p/n 209999, lot number rob 281 shows no additional complaints related to the failure in this investigation.Conclusion: the logs from the event date were reviewed.No errors for blocked arrays were observed.There was indication of multiple peripheral read errors that could indicate an issue with the anspach.Gsp ticket (b)(4) reports that a service engineer visited the site and was not able to duplicate the event.The data at this time shows no system defect, no malfunction is suspected.

Event Description

The surgeon was performing a partial knee arthroplasty using the robotic arm interactive orthopedic system (rio).During burring of bone the surgeon could not burr for longer than 1 to 2 seconds without the power shutting off and an error popping up.The case had approximately a 30 minute delay but was then completed successfully.

• Brand Name: 3.0 RIO® ROBOTIC ARM - MICS
• Type of Device: STEREOTAXIC DEVICE, ROBOTIC
• 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: 5965584
• MDR Text Key: 55208653
• Report Number: 3005985723-2016-00295
• 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: 08/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2016
• 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?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/31/2016
• 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): Other