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

Catalog Number 209999

Device Problems Incorrect Measurement (1383); Output Problem (3005)

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

Event Date 06/17/2019

Event Type  malfunction  

Manufacturer Narrative

As part of the 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

During a tka procedure, while trialing the femoral component, the surgeon indicated that the trial is sitting flush against all cuts of bone with exception to the anterior chamfer.He indicated that the gap was somewhere between 1-2 mm.I instructed him to check the cut with the planar probe, which indicated we were only 0.2 mm beyond our desired resection level.He wanted to run the saw over the chamfer cut again to see if there was any "lip" preventing the trial from sitting down.After cutting the trial yielded the same result.Because he felt like the gap was big enough he decided to cement the femur instead of going cement-less on the femoral component.Case type: tka.Surgical delay: =15 minutes.

Manufacturer Narrative

An event regarding inaccurate resection involving 3.0 rio robotic arm - mics, catalog: 209999 was reported.Method & results: device history review: a review of the dhr associated with rio 231 found quality inspection procedures successfully passed.Complaint history: a search of the complaint database under device identification pn 209999 reports similar complaints for tka software - inaccurate resection.Conclusion: not performed as case session data was not provided.

Event Description

During a tka procedure, while trialing the femoral component, the surgeon indicated that the trial is sitting flush against all cuts of bone with exception to the anteriror chamfer.He indicated that the gap was somewhere between 1-2 mm.I instructed him to check the cut with the planar probe, which indicated we were only 0.2 mm beyond our desired resection level.He wanted to run the saw over the chamfer cut again to see if there was any "lip" preventing the trial from sitting down.After cutting the trial yielded the same result.Because he felt like the gap was big enough he decided to cement the femur instead of going cement-less on the femoral component.Case type: tka.Surgical delay: =15 minutes.

• 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: 8769334
• MDR Text Key: 150888690
• Report Number: 3005985723-2019-00500
• 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: 11/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: No
• Initial Date Manufacturer Received: 06/17/2019
• Initial Date FDA Received: 07/08/2019
• Supplement Dates Manufacturer Received: 10/30/2019
• Supplement Dates FDA Received: 11/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 60 YR