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

Catalog Number 209999

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Bone Fracture(s) (1870); No Known Impact Or Consequence To Patient (2692)

Event Date 06/28/2017

Event Type  Injury  

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

Completed unicompartmental case.Surgeon bumped base array with patient's leg when flexing leg.Re-registration of the rio was required.Completed second registration successfully and returned to bone prep.Conducted ct view check, passed.Bone prep completed.When surgeon placed the femoral trial on the femur, the resected bone area did not match the trial perfectly.The post holes seemed to be off center.The doctor proceeded to forcefully impact the femur into the holes.This led to a small crack in the femoral condyle.Surgeon utilized a cancellous bone screw to repair the crack and completed manual burring with manual instrumentation before implanting final implant.Plans, logs, etc., uploaded to the complaints folder in folder named "(b)(6)." case type: pka, surgical delay: 15 minutes.

Manufacturer Narrative

Reported event: an event regarding inaccurate femoral placement involving 3.0 rio robotic arm - mics, catalog: 209999 was reported.Method & results: device history review: a review of the dhr associated with rio 482 found quality inspection procedures successfully passed.Complaint history: based on the device identification (pn 209999) the complaint databases were reviewed from 2011 to present for similar reported events regarding inaccurate femoral placement.There were only 5 other reported events ((b)(4)).Conclusion: case x-rays were requested, but are not available for review.The session and vplog data from the case was reviewed.An analysis of the checkpoints values, bone registration values, rio registration values, and bone preparation checkpoint values was completed.The data at this time shows all system verification values were within tolerance; the mako operated as expected.No system defect or malfunction is suspected.

Event Description

Completed unicompartmental case.Surgeon bumped base array with patient's leg when flexing leg.Re-registration of the rio was required.Completed second registration successfully and returned to bone prep.Conducted ct view check, passed.Bone prep completed.When surgeon placed the femoral trial on the femur, the resected bone area did not match the trial perfectly.The post holes seemed to be off center.The doctor proceeded to forcefully impact the femur into the holes.This led to a small crack in the femoral condyle.Surgeon utilized a cancellous bone screw to repair the crack and completed manual burring with manual instrumentation before implanting final implant.Plans, logs, etc., uploaded to the complaints folder in folder named ¿(b)(6)¿.Case type: pka.Surgical delay: 15 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
• Manufacturer (Section G): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer Contact: bethany hinson ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 6696303
• MDR Text Key: 79359085
• Report Number: 3005985723-2017-00286
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112507
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 209999
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/28/2017
• Initial Date FDA Received: 07/09/2017
• Supplement Dates Manufacturer Received: 10/09/2017
• Supplement Dates FDA Received: 10/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other