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

Catalog Number 209999

Device Problem Output Problem (3005)

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

Event Date 07/22/2019

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

The size 6 pka femoral trial did not fit after we burred for a size 6 pka left medial femoral trial.Had to downsize to a size 5 left medial trial, move the implant approx 1 mm proximal, reburr and then re-trial.Session files, logs, etc are loaded in complaints folder under "(b)(4)." case type: pka.Surgical delay: 16-30 minutes.

Manufacturer Narrative

Reported event: an event regarding inaccurate resection involving 3.0 rio robotic arm - mics, catalog: 209999 was reported.Method & results: device history review: a review of the dhr associated with rio 338 found quality inspection procedures successfully passed.Complaint history: a search of the complaint database under device identification pn 209999 reports similar complaints for pka software - inaccurate resection.The complaint record numbers are: (b)(4).Conclusion: a review of this case shows minimal irregularities in the procedure.Bone registration error was within an adequate range and all verification spheres were passed.There were no velocity traps and nothing to suggest movement with arrays.I was able to verify the surgeons workflow and confirmed that it was necessary for him/her to adjust to a smaller implant and recut.It is not clear if the size 5 implant was what was implanted after however.The gap analysis during final trialing look good with all poses showing minimal tightness/looseness in the soft tissue.Based on the data form the case it does not appear the application behaved in an unintended manor.

Event Description

The size 6 pka femoral trial did not fit after we burred for a size 6 pka left medial femoral trial.Had to downsize to a size 5 left medial trial, move the implant approx 1 mm proximal, reburr and then re-trial.Session files,logs, etc are loaded in complaints folder under (b)(4).Case type: pka.Surgical delay: 16-30 minutes.

• 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: 8871206
• MDR Text Key: 155480736
• Report Number: 3005985723-2019-00577
• 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: 10/01/2019

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 Catalogue Number: 209999
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/22/2019
• Initial Date FDA Received: 08/07/2019
• Supplement Dates Manufacturer Received: 09/27/2019
• Supplement Dates FDA Received: 10/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization