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

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 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.This is for the second tka procedure.

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.This is for the second tka procedure.

Manufacturer Narrative

Reported event: 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.Method & results: product evaluation and results: a review of the vp logs was reviewed from the day of the case.Post-op x-rays and crisis logs were not provided.A review of the 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.All data provided show that the mako system operated within specification.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 via npr.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 pn 209999 reports similar complaints for tka software - software error.Conclusions: a review of the vp logs was reviewed from the day of the case.Post-op x-rays and crisis logs were not provided.A review of the 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.All data provided show that the mako system operated within specification.No system software defect or malfunction is suspected.No additional investigation or specific actions are required at this time.

• 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: 9292458
• MDR Text Key: 180401806
• Report Number: 3005985723-2019-00792
• 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: 09/14/2020

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: 11/06/2019
• Initial Date FDA Received: 11/07/2019
• Supplement Dates Manufacturer Received: 08/17/2020
• Supplement Dates FDA Received: 09/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other