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

Catalog Number 209999

Device Problems Mechanical Problem (1384); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/25/2018

Event Type  malfunction  

Manufacturer Narrative

As part of 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

The doctor completed the distal cut, then during the posterior chamfer cut, an angle discrepancy error occurred and the arm locked up.I asked the doctor to put the green probe to the sawblade and it did not pass.Scrub tried to reregister the robot twice and both failed.I performed arm status check and everything was green.Then the scrub tech performed angle discrepancy check and there was an j6 error.With risk of it occurring again the doctor decided to finish it manually.I then shut it off, turned it back on, and it passed angle discrepancy check.The case was completed manually successfully with no patient harm.Tka case delayed 16-30 minutes.The fse was able to be on site later that day and performed maintenance.There was debris on the j6 encoder, so the fse adjusted and cleaned the j6 motor and joint encoder.

Manufacturer Narrative

Reported event: the doctor completed the distal cut, then during the posterior chamfer cut, an angle discrepancy error occurred and the arm locked up.Device evaluation and results: per (b)(4): inspected for reported issue, found debris on j6 joint encoder glass scale.Also j6 joint encoder and j6 motor encoder requires adjustment.Successfully cleaned j6 joint encoder glass scale.Successfully adjusted j6 joint encoder.Successfully adjusted j6 motor encoder.System successfully passed all validation testing.Product history review: a review of the dhr associated with (b)(4) found quality inspection procedures successfully passed.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 209999, serial number (b)(4) shows no additional complaints related to the failure in this investigation.Conclusions: system ready for clinical use.Corrective action/preventive action: no action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.

Event Description

The doctor completed the distal cut, then during the posterior chamfer cut, an angle discrepancy error occurred and the arm locked up.I asked the doctor to put the green probe to the sawblade and it did not pass.Scrub tried to reregister the robot twice and both failed.I performed arm status check and everything was green.Then the scrub tech performed angle discrepancy check and there was an j6 error.With risk of it occurring again the doctor decided to finish it manually.I then shut it off, turned it back on, and it passed angle discrepancy check.The case was completed manually successfully with no patient harm.Tka case delayed 16-30 minutes.The fse was able to be onsite later that day and performed maintenance.There was debris on the j6 encoder, so the fse adjusted and cleaned the j6 motor and joint encoder.

• 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: 7660734
• MDR Text Key: 113322280
• Report Number: 3005985723-2018-00407
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486030407
• UDI-Public: 00848486030407
• Combination Product (y/n): N
• PMA/PMN Number: K170581
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 209999
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization