MAUDE Adverse Event Report: MAKO SURGICAL CORP. 3.0 RIO ROBOTIC ARM - MICS; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 209999

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Positioning Problem (3009); Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/09/2021

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

Surgeon reported that a knee was planned for varus and implanted.Post op x-rays showed the tibial baseplate (and the patient's knee) in valgus.There are currently no patient complaints, and no treatment plan beyond observation and assessment, but the surgeon is growing increasingly concerned as this is the third patient this year.Sales manager confirmed that the surgeon implants approximately 30 mako knees per month.After the first case, surgeon was advised that the points were too close together, and the sales manager confirmed that the surgeon is more mindful of the point spread since then.Surgeon and sales manager are requesting investigation results.Images, logs and session files can be provided.

Event Description

Surgeon reported that a knee was planned for varus and implanted.Post op x-rays showed the tibial baseplate (and the patient's knee) in valgus.There are currently no patient complaints, and no treatment plan beyond observation and assessment, but the surgeon is growing increasingly concerned as this is the third patient this year.Sales manager confirmed that the surgeon implants approximately 30 mako knees per month.After the first case, surgeon was advised that the points were too close together, and the sales manager confirmed that the surgeon is more mindful of the point spread since then.Surgeon and sales manager are requesting investigation results.Images, logs and session files can be provided.

Manufacturer Narrative

Reported event: an event regarding inaccurate resection involving a mako tka software was reported.The event was confirmed as user error.Method & results: product evaluation and results: review of the case session files noted the following: the session and vp log data from the case was reviewed.An analysis of the implant plan, checkpoint check values, registration values, probe check values, rio registration and verification values, bone preparation checkpoints values, cutting tool location, and post-operative x-rays was completed.The data at this time shows that all system verification values were within the accuracy tolerance region; no system defect or malfunction is suspected.The rio cut all five femoral planes, as well as the tibial planes, on target based on the burrlist plane analysis.The anterior chamfer, distal, and posterior chamfer cuts appear to have relatively high angular errors, which indicates a user¿s propensity to lean on the robotic arm.Both passes of the tibial resection appear to show the user resecting the plane in more valgus than planned lateral compartment slightly deeper.It was found that the user shifted the tibial resection slightly deeper for a second pass and recorded most of the burrlist for this second pass on the lateral compartment, while also performing the resection slightly deep.This will lead to a deeper lateral compartment than medial, which after impaction, will result in a valgus alignment of the tibial component.Upon analyzing the registration pattern performed by the doctor, it was found that points were collected largely on the medial side of the tibia only four points were captured past the midline.The registration pattern collected in this case can lead to a reduction in overall accuracy and could impact bone preparation.The post-operative x-rays were also reviewed.Some leg rotation relative to the camera can be seen in the image, which can lead to a perceived valgus angulation.Finally, the user just barely passed blue sharp probe check by 0.03mm.This would indicate an issue with either the probe tip or the divot on the ee array.Any issues with the sharp probe tip will have an impact on registration accuracy.Please see some best cutting practices below.This is a list of items that we have learned can lead to resection inaccuracies or impact our perception of the joint angles.Cutting technique: let the saw do the work, don't push/pull off plane light touch.Registration pattern: ensure to follow the recommended pattern.Imaging technique: ensure that the camera is positioned directly in line with the knee¿s ap axis and that the knee is not flexed or extended.Clinician review: no medical records were received for review with a clinical consultant.Product history review: a review of device history records shows that rob271 was inspected on 24 jan 2014 and the quality inspection procedures were completed with no reported discrepancies complaint history review: a review of complaints in trackwise related to p/n 209999, robot number: (b)(6) shows 1 similar complaints for tka software - inaccurate resection.Conclusions: the alleged failure mode was confirmed as user error.The data at this time shows that all system verification values were within the accuracy tolerance region; no system defect or malfunction is suspected.Successfully completed all checks, verifications, and calibrations.System is ready for clinical use.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.

• Brand Name: 3.0 RIO ROBOTIC ARM - MICS
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 12092397
• MDR Text Key: 259492501
• Report Number: 3005985723-2021-00118
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 09/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2021
• 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
• Device Lot Number: ROB271
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other