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

Case number: 04266824, (b)(4) - mps (b)(6) reported femur cuts off.Case type: tka.Update: "upon cleaning out the joint after making straight cuts on the femur, the surgeon stated that the femur was notching.We checked our cut with the planar probe, and we were within the tolerance of accuracy (showed under 1.0 deg/mm).We validated that registration was good when we changed to the angled blade for the last 2 femoral cuts.The software allowed us to go into the distal femur cut upon checking the ¿checkpoint¿ (note: no check points were used.The surgeon picks a spot on the femoral array clamp and uses that as his check point¿off label)." which cuts were inaccurate? anterior femur cut.How was the cut inaccurate? notching (deep) (warning notching 3 degrees away from being present).What is the estimated discrepancy ? 2-3 degrees.Planar probe was used and it showed that we were accurate (under 1mm) to the cut.

Manufacturer Narrative

Reported event: an event regarding implant notching involving 3.0 rio® robotic arm - mics, catalog: 209999 was reported.It was reported ¿case number: (b)(4), mps (b)(6) reported femur cuts off.Upon cleaning out the joint after making straight cuts on the femur, the surgeon stated that the femur was notching.We checked our cut with the planar probe, and we were within the tolerance of accuracy (showed under 1.0 deg/mm).We validated that registration was good when we changed to the angled blade for the last 2 femoral cuts.The software allowed us to go into the distal femur cut upon checking the ¿checkpoint¿ (note: no check points were used.The surgeon picks a spot on the femoral array clamp and uses that as his check point off label).¿ further details provided through customer contact stated; which cuts were inaccurate? anterior femur cut.How was the cut inaccurate? notching (deep) (warning notching 3 degrees away from being present).What is the estimated discrepancy ? 2-3 degrees.Planar probe was used and it showed that we were accurate (under 1mm) to the cut.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 the femoral array was sub-optimally set up as indicated in the complaint description and by high checkpoint error values from the logs.Suboptimal array set up is deemed as the root cause of the anterior cut resulting in a notch on the femur.As per work order number: (b)(4), case number: (b)(4).Problem reproduced? yes.Work performed.Realigned the j2 bump stop angles to the factory settings.Successfully performed all verification testing following the service manual.Deposition.System investigation completed successfully as per service manual.All system checks and tests passed; system is ready for use.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 (b)(6) 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 the femoral array was sub-optimally set up as indicated in the complaint description and by high checkpoint error values from the logs.Suboptimal array set up is deemed as the root cause of the anterior cut resulting in a notch 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.

Event Description

Case number: (b)(4), mps (b)(6) reported femur cuts off.Case type: tka.Update: "upon cleaning out the joint after making straight cuts on the femur, the surgeon stated that the femur was notching.We checked our cut with the planar probe, and we were within the tolerance of accuracy (showed under 1.0 deg/mm).We validated that registration was good when we changed to the angled blade for the last 2 femoral cuts.The software allowed us to go into the distal femur cut upon checking the ¿checkpoint¿ (note: no check points were used.The surgeon picks a spot on the femoral array clamp and uses that as his check point off label)." which cuts were inaccurate? anterior femur cut.How was the cut inaccurate? notching (deep) (warning notching 3 degrees away from being present).What is the estimated discrepancy ? 2-3 degrees.Planar probe was used and it showed that we were accurate (under 1mm) to the cut.

• 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: 9233101
• MDR Text Key: 174899128
• Report Number: 3005985723-2019-00755
• 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: 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2019
• 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?: Yes
• Date Manufacturer Received: 04/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization