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 Problems Tissue Damage (2104); Injury (2348)

Event Date 08/14/2019

Event Type  Injury  

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 was proceeding as normal.Robot operating as normal.Surgeon trialed and was happy with results.Arrays and pins were taken off of the patient.Surgeon chose to cement.4 femur, 4 tibia, 9 poly insert.Cement was applied to implants and implants were put on patient, including cs poly.Surgeon cleaned up cement around implants using various tools.Surgeon let down the turnicate and pulled leg into extension and a pool of blood formed.This is when it was noticed that an artery was nicked.Polyethylene insert was taken out.Bleeding stopped when leg was in flexion, but continues when pulled into extension.Doppler used to check pulse on ankle.Call made to a vascular surgeon to come in and assess.Awaiting outcome.Case type: tka.Surgical delay: 30-60 minutes.

Manufacturer Narrative

Reported event: an event regarding inaccurate resection (user error) involving 3.0 rio® robotic arm mics, catalog: 209999 was reported.It was reported that the ¿case was proceeding as normal.Robot operating as normal.Surgeon trailed and was happy with results.Arrays and pins were taken off of the patient.Surgeon chose to cement.4 femur, 4 tibia, 9 poly insert.Cement was applied to implants and implants were put on patient, including cs poly.Surgeon cleaned up cement around implants using various tools.Surgeon let down the tunicate and pulled leg into extension and a pool of blood formed.This is when it was noticed that an artery was nicked.Polyethylene insert was taken out.Bleeding stopped when leg was in flexion, but continues when pulled into extension.Doppler used to check pulse on ankle.Call made to a vascular surgeon to come in and assess.Awaiting outcome.¿ method & results: product evaluation and results: the case files provided (crisis logs and patient session file) were reviewed.Areas of investigation included the implant plan, robot registration, bone registration, and cutting tool history.A review of the tool excursion during the tibia and posterior resections showed that the cutting tool did not venture beyond 1.25mm from the stereotactic boundary (the control limit).These limits and the haptic boundary profile are designed to protect soft tissue structures.Soft tissue retraction is not monitored by the mako system.A phone call with the mps indicated that damage to the popliteal artery likely occurred with manual instrumentation while the bone was being cleared of osteophytes.The data at this time shows that the mako system operated within specification.No system defect or malfunction is suspected.Product history review: review of the device history records associated with rio 833 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 no similar complaints.Conclusions: inaccurate resection was not confirmed through inspection of the provided session files.A review of the tool excursion during the tibia and posterior resections showed that the cutting tool did not venture beyond 1.25mm from the stereotactic boundary (the control limit).These limits and the haptic boundary profile are designed to protect soft tissue structures.Soft tissue retraction is not monitored by the mako system.A phone call with the mps indicated that damage to the popliteal artery likely occurred with manual instrumentation while the bone was being cleared of osteophytes.The data at this time shows that the mako system operated within specification.No system defect or malfunction is suspected.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.Corrective action/preventive action: a search of the nc/capa database under device identification pn: 209999 was not performed as no specific failure modes were identified.

Event Description

Case was proceeding as normal.Robot operating as normal.Surgeon trailed and was happy with results.Arrays and pins were taken off of the patient.Surgeon chose to cement.4 femur, 4 tibia, 9 poly insert.Cement was applied to implants and implants were put on patient, including cs poly.Surgeon cleaned up cement around implants using various tools.Surgeon let down the tunicate and pulled leg into extension and a pool of blood formed.This is when it was noticed that an artery was nicked.Polyethylene insert was taken out.Bleeding stopped when leg was in flexion, but continues when pulled into extension.Doppler used to check pulse on ankle.Call made to a vascular surgeon to come in and assess.Awaiting outcome.Case type: tka.Surgical delay: 30-60 minutes.

• 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: 8928825
• MDR Text Key: 155497518
• Report Number: 3005985723-2019-00600
• 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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 209999
• Device Catalogue Number: 209999
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/14/2019
• Initial Date FDA Received: 08/25/2019
• Supplement Dates Manufacturer Received: 03/28/2020
• Supplement Dates FDA Received: 04/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR