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

Catalog Number 209999

Device Problems Use of Device Problem (1670); Insufficient Information (3190)

Patient Problems Bone Fracture(s) (1870); No Known Impact Or Consequence To Patient (2692)

Event Date 10/31/2017

Event Type  Injury  

Manufacturer Narrative

It was reported that the doctor decided to a stryker navigation system with the mako system after being advised against doing so. Utilizing the stryker navigation system with the mako robot is an off-label use. The difference in alignment noticed during surgery is therefore due to user error. The data at this time shows that the rio operated as expected. No system defect or malfunction is suspected.

Event Description

In the 2nd mako/strykernav case (10/31/2017), after making his cuts which were "acceptable" he manually completed the box cut for the ps femur. He impacted the trial and then noted that there was a fracture on the medial aspect of the femoral condyle. He then stated that "it didn't look like the box cut was big enough" and ordered an x-ray. He then opted to use a stryker ts fluted stem (12mm/100mm/ts) and a size 7 rt ts femur. He repaired the fracture with a screw and finished the knee procedure. There was a surgical delay of 15 minutes to repair the fracture.

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

In the 2nd mako/strykernav case (10/31/2017), after making his cuts which were "acceptable" he manually completed the box cut for the ps femur. He impacted the trial and then noted that there was a fracture on the medial aspect of the femoral condyle. He then stated that "it didn't look like the box cut was big enough" and ordered an x-ray. He then opted to use a stryker ts fluted stem (12mm/100mm/ts) and a size 7 rt ts femur. He repaired the fracture with a screw and finished the knee procedure. There was a surgical delay of 15 minutes to repair the fracture.

• 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
• Manufacturer (Section G): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer Contact: bethany hinson ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 7017442
• MDR Text Key: 249799677
• Report Number: 3005985723-2017-00538
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 209999
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/21/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 11/10/2017 Patient Sequence Number: 1