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

Model Number 209999

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)

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

Event Date 10/16/2019

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 the straight cuts on the femur (anterior), a vizidisc popped off of the femur array.The surgeon pressed the array back down and then checked his anterior cut to find it was notching.We validated that the registration was off (both by checking the cut with the planar probe and check point).We re-registered the bone where we had not made cuts yet, and completed the femur cuts.The plan was planned 2 degrees away from notching.He redid his cuts manually and ended up going ts.(note: no checkpoints were used.The surgeon picks a spot on the array clamp and uses that as the checkpoint.Case type: tka.Surgical delay: 15 minutes.Procedure was completed manually.

Event Description

During the straight cuts on the femur (anterior), a vizidisc popped off of the femur array.The surgeon pressed the array back down and then checked his anterior cut to find it was notching.We validated that the registration was off (both by checking the cut with the planar probe and check point).We re-registered the bone where we had not made cuts yet, and completed the femur cuts.The plan was planned 2 degrees away from notching.He redid his cuts manually and ended up going ts.(note: no checkpoints were used.The surgeon picks a spot on the array clamp and uses that as the checkpoint.Case type: tka.Surgical delay: =15 minutes.Procedure was completed manually.

Manufacturer Narrative

Reported event: an event regarding implant notching involving 3.0 rio® robotic arm - mics, catalog: 209999 was reported.It was reported ¿during the straight cuts on the femur (anterior), a vizidisc popped off of the femur array.The surgeon pressed the array back down and then checked his anterior cut to find it was notching.We validated that the registration was off (both by checking the cut with the planar probe and check point).We re-registered the bone where we had not made cuts yet and completed the femur cuts.The plan was planned 2 degrees away from notching.He redid his cuts manually and ended up going ts.(note: no checkpoints were used.The surgeon picks a spot on the array clamp and uses that as the checkpoint.¿ method & results: product evaluation and results: the problem statement for this complaint investigation was regarding the system failing to prevent the anterior cut to be prepared deeper than planned, resulting in a notch on the femur.Upon investigating, it may be concluded that a combination of sub-optimal bone registration and bone preparation was the root cause of the notch that was observed on the femur.Product history review: review of the device history records associated with rio 640 indicate quality inspection procedures were completed with no reported discrepancies.Complaint history review: a search of the complaint database under device identification pn 209999 reports similar complaints for tka software - inaccurate resection.The complaint record numbers are: (b)(4).Conclusions: the problem statement for this complaint investigation was regarding the system failing to prevent the anterior cut to be prepared deeper than planned, resulting in a notch on the femur.Upon investigating, it may be concluded that a combination of sub-optimal bone registration and bone preparation was the root cause of the notch that was observed on the femur.No additional investigation or specific actions are required at this time.If additional information is received such as the session files, then the complaint will be reopened.Corrective action/preventive action: a search of the nc/capa database under device identification pn 209999 reports no records related to tha software - inaccurate resection.

• 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: 9233098
• MDR Text Key: 170315787
• Report Number: 3005985723-2019-00758
• 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: 04/13/2020

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 Model Number: 209999
• Device Catalogue Number: 209999
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/16/2019
• Initial Date FDA Received: 10/24/2019
• Supplement Dates Manufacturer Received: 03/29/2020
• Supplement Dates FDA Received: 04/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization