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

Model Number 209999

Device Problems Computer Software Problem (1112); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 04/02/2019

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

Patient had tka with mako on 4/1 and fell the morning of 4/2 and fractured the femur where surgeon feels implant was notching femur.Case type: tka.

Manufacturer Narrative

Reported event: an event regarding periprosthetic fracture due to implant notching involving 3.0 rio® robotic arm - mics, catalog: 209999 was reported.It was reported ¿patient had tka with mako on 4/1 and fell the morning of 4/2 and fractured the femur where surgeon feels implant was notching femur.¿ method & results: product evaluation and results: a review of the session file, software log file, and crisis log files from the reported event was completed to investigate the reported notching event.A review of the presurgery checks, robot registration and verification, bone registration and checkpoint capture, and warnings and errors showed that all quality metrics were within passing range and there were no logged warnings or errors that may have contributed to the reported event.A review of the implant plan showed that the implant flange was planned nearly coincident to the femur bone surface at a component flexion of 3.9 degrees.The provided x-rays show some run-off above the anterior flange of the component, which can be seen as planned on the implant planning page.A review of the tool position during the anterior resection showed that some bone may have remained near the implant anterior flange, which may have contributed to the reported event.A review of the available data showed that the mako system operated within specifications.No system defect or malfunction is suspected.Product history review: review of the device history records associated with rio 109 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 similar complaints for tka software - software error.Conclusions: a review of the session file, software log file, and crisis log files from the reported event was completed to investigate the reported notching event.A review of the presurgery checks, robot registration and verification, bone registration and checkpoint capture, and warnings and errors showed that all quality metrics were within passing range and there were no logged warnings or errors that may have contributed to the reported event.A review of the implant plan showed that the implant flange was planned nearly coincident to the femur bone surface at a component flexion of 3.9 degrees.The provided x-rays show some run-off above the anterior flange of the component, which can be seen as planned on the implant planning page.A review of the tool position during the anterior resection showed that some bone may have remained near the implant anterior flange, which may have contributed to the reported event.A review of the available data showed that the mako system operated within specifications.No system defect or malfunction is suspected.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.

Event Description

Patient had tka with mako on 4/1 and fell the morning of 4/2 and fractured the femur where surgeon feels implant was notching femur.Case type: tka.

• 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: 8517692
• MDR Text Key: 142038303
• Report Number: 3005985723-2019-00298
• 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: 05/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2019
• Is this an Adverse Event Report?: Yes
• 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: 04/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 61 YR