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

Catalog Number 209999

Device Problems Device Operates Differently Than Expected (2913); Insufficient Information (3190)

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

Event Date 07/21/2017

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 the case we had to do multiple robot registrations and on the femur we had to redo the checkpoints as well.Doctor (b)(6) at that time want to proceed manually.Case type: (b)(6).Surgical delay: approximately 5 to 7 min.

Manufacturer Narrative

Reported event: the reported device is a 3.0 rio® robotic arm - mics, catalog: 209999.Device history review: a review of the dhr associated with rio 285 found quality inspection procedures and the pt review 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 having to register the robot multiple times.There were no other reported events for the listed catalog number.Conclusion: the session and vp log data from the case was reviewed.An analysis of the session file, implant planning page, the checkpoints values, bone registration values, rio registration values, bone preparation checkpoints values, burrlist, sequence of events, and base array placement was performed.The reason that rio registration had to be performed multiple times was that the base array was either not secured properly, bumped repeatedly, or a combination of the two.This leads to a reduction in accuracy and causes the system to lose track of array relationships.There are three likely causes for base array movement: a loose fisso arm.If the base array arm is not locked tightly into position, the arm could slowly fall due to gravity.Minor movement could cause large translation of the base array with regard to the camera due to the distance between the two.The base array or fisso arm is bumped.If caution is not taken to avoid the fisso arm or base array in the or, the array could be bumped and move.It has been shown that if the fisso arm is locked in position very close to the shell of j1, the shell could actually bump the arm.This may also be cause by a tight drape over the robot, where tension on the drape pulls the arm in a direction.All verification values were within the accuracy tolerance region.The mako operated as expected.No system defect or malfunction is suspected.

Event Description

During the case we had to do multiple robot registrations and on the femur we had to redo the checkpoints as well.Dr.(b)(6) at that time want to proceed manually.Case type: tka.Surgical delay: approximately 5 to 7 min.

• 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: 6745568
• MDR Text Key: 81141851
• Report Number: 3005985723-2017-00343
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143752
• 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: 12/19/2017

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/21/2017
• Initial Date FDA Received: 07/26/2017
• Supplement Dates Manufacturer Received: 12/05/2017
• Supplement Dates FDA Received: 12/19/2017
• 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 Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 70 YR