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

Model Number 209999

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005); Positioning Problem (3009)

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

Event Date 06/27/2019

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

After using the planar saw to cut the posterior femur dr.(b)(6) placed the femoral trial in and noticed a 2mm gap on the posterior femur.Case type: pka.

Event Description

After using the planar saw to cut the posterior femur dr.Placed the femoral trial in and noticed a 2mm gap on the posterior femur.Case type: pka.

Manufacturer Narrative

Reported event: an event regarding inaccurate resection involving a mako pka software was reported.The event was not confirmed.Method & results: review of the log/session files has not been completed as the files were not made available for evaluation.If the files are received by stryker then the complaint will be reopened and log/session files reviewed.Clinician review: no medical records were received for review with a clinical consultant.Product history review: a review of device history records shows that (b)(6) was inspected on 27/01/2012 and the quality inspection procedures were completed with no reported discrepancies complaint history review: a review of complaints in trackwise related to p/n 209999, robot number: (b)(6) shows 0 similar complaints for pka software - inaccurate resection.Conclusions: the exact cause of the event could not be determined because insufficient information was made available for evaluation.Review of the log/session files has not been completed within 90days of the complaint being opened.A review of the case session/log data is needed to complete a full investigation for determining root cause.In addition to a review of the log/session, a field service engineer conducts scheduled maintenance on the robot to ensure the robot is system ready.Product surveillance will continue to monitor for trends.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.H3 other text : device not returned.

Manufacturer Narrative

Update to conclusion reported event an event regarding inaccurate resection involving a mako pka software was reported.The event was not confirmed.Method & results: review of the log/session files found the following: there were no indications of system failure based on the logs provided.There were no indications of issues with system accuracy based on the logs.Bone and robot registration values were within the confidence range and on call checkpoints before entering bone prep were accurate, suggesting that arrays had not moved.Clinician review: no medical records were received for review with a clinical consultant.Product history review: a review of device history records shows that rob183 was inspected on 27/01/2012 and the quality inspection procedures were completed with no reported discrepancies complaint history review: a review of complaints in trackwise related to p/n 209999, robot number: rob183 shows 0 similar complaints for pka software - inaccurate resection.Conclusions: the failure was reviewed through return of the provided log/session files.The data at this time shows that all system verification values were within the accuracy tolerance region; no system 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.

Event Description

After using the planar saw to cut the posterior femur dr.Placed the femoral trial in and noticed a 2mm gap on the posterior femur.Case type: pka.

• 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: 8785491
• MDR Text Key: 150855072
• Report Number: 3005985723-2019-00504
• 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,Followup
• Report Date: 07/12/2021

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?: No
• Initial Date Manufacturer Received: 06/27/2019
• Initial Date FDA Received: 07/12/2019
• Supplement Dates Manufacturer Received: 12/08/2020; 06/15/2021
• Supplement Dates FDA Received: 12/29/2020; 07/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other