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

Catalog Number 209999

Device Problems Computer Software Problem (1112); Output Problem (3005)

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

Event Date 12/06/2018

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

During bone prep, the saw blade checkpoint on the angled saw attachment passed.The femoral checkpoint passed as well.We then proceeded to make the distal and posterior chamfer cuts.When attempting to pass the saw blade checkpoint on the straight saw attachment the checkpoint error read 4.1mm.The blade assembly was checked, then the robot was registered again.The rest of the cuts were then completed.When dr.Wong placed the femoral trial on the bone he noticed the trial was not seated on the distal and posterior chamfer cuts.He used a ruler to measure the height of the gap which measured 4mm.Final results were good.No patient harm.

Event Description

During bone prep, the saw blade checkpoint on the angled saw attachment passed.The femoral checkpoint passed as well.We then proceeded to make the distal and posterior chamfer cuts.When attempting to pass the saw blade checkpoint on the straight saw attachment the checkpoint error read 4.1mm.The blade assembly was checked, then the robot was registered again.The rest of the cuts were then completed.When dr.Wong placed the femoral trial on the bone he noticed the trial was not seated on the distal and posterior chamfer cuts.He used a ruler to measure the height of the gap which measured 4mm.Final results were good.No patient harm.

Manufacturer Narrative

Reported event: an event regarding inaccurate resection and poor trial fit during a total knee procedure involving 3.0 rio robotic arm - mics, catalog: 209999 was reported.Method & results: device history review: a review of the dhr associated with rio 732 found quality inspection procedures successfully passed.Complaint history: based on the device identification (pn 209999) the complaint databases were reviewed from 2011 to present for similar reported events regarding inaccurate resection and trial gaps.There were other reported events for the listed catalog number (b)(4).Conclusion: an analysis of the warnings in the crisis log file, application workflow, femur checkpoint values, femur registration values, rio registration and erification values, bone preparation checkpoint values and burr-list accuracy was completed.No system defect or malfunction is suspected.

• 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: 8202730
• MDR Text Key: 131716279
• Report Number: 3005985723-2018-00796
• 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: 07/15/2019

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?: Yes
• Initial Date Manufacturer Received: 12/06/2018
• Initial Date FDA Received: 12/28/2018
• Supplement Dates Manufacturer Received: 06/30/2019
• Supplement Dates FDA Received: 07/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization