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

Model Number 209999

Device Problem Output Problem (3005)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/06/2019

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

Mako (b)(4) had a problem during 2 tka procedures.After good preparation of all the associated stuff, good bone registration, good intra op planning, the anterior cut gave us problem.We saw notching in both cases even if wasn¿t planned.Results showed anterior notching and overhang on the anterior shield.Autoarm check ok at the end of procedure.Attachments will follow if requested as too big.

Event Description

Mako rio272 had a problem during 2 tka procedures.After good preparation of all the associated stuff, good bone registration, good intra op planning, the anterior cut gave us problem.We saw notching in both cases even if wasn¿t planned.Results showed anterior notching and overhang on the anterior shield.Autoarm check ok at the end of procedure.Attachments will follow if requested as too big.

Manufacturer Narrative

Reported event: it was reported that mako rio272 had a problem during 2 tka procedures.After good bone registration, good intra op planning, the anterior cut gave a problem.It was noted that notching occurred in both cases.Results showed anterior notching and overhang on the anterior shield.Autoarm check ok at the end of procedure.Method & results: product evaluation and results: a review of the vp logs was conducted.The crisis logs were not provided.Femur checkpoint and registration passed without issue and the robot was successfully registered.The implant plan looks to align with the patient.A review of the cutting tool indicates that the surgeon did not remove all of the bone on the anterior face of the femur.A small amount of bone on the proximal portion of the anterior face could have contributed to the notching event.It is recommended the surgeon take great care to ensure that all bone is removed prior to implantation, especially with complicated patient anatomy.No system software defect or malfunction is suspected product history review: a review of device history records shows that rob272 was inspected on 3/3/2014 and was handled.A review of the data revealed that the non-conformances is not related to the failure alleged in this complaint.Complaint history review: a search of the complaint database under device identification (b)(4) reports similar complaints for tka software - inaccurate resection.Conclusions: a review of the vp logs was conducted.The crisis logs were not provided.Femur checkpoint and registration passed without issue and the robot was successfully registered.The implant plan looks to align with the patient.A review of the cutting tool indicates that the surgeon did not remove all of the bone on the anterior face of the femur.A small amount of bone on the proximal portion of the anterior face could have contributed to the notching event.It is recommended the surgeon take great care to ensure that all bone is removed prior to implantation, especially with complicated patient anatomy.No system software defect or malfunction is suspected product surveillance will continue to monitor for trends.No additional investigation or specific actions are required at this time.If additional information is received, then the complaint will be reopened.System is ready for use.H3 other text : device not returned.

• 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: 9292457
• MDR Text Key: 165491411
• Report Number: 3005985723-2019-00791
• 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: distributor
• Type of Report: Initial,Followup
• Report Date: 09/18/2020

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 Model Number: 209999
• Device Catalogue Number: 209999
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/07/2019
• Initial Date FDA Received: 11/07/2019
• Supplement Dates Manufacturer Received: 08/21/2020
• Supplement Dates FDA Received: 09/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization