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

Catalog Number 209999

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

Patient Problems Discomfort (2330); No Known Impact Or Consequence To Patient (2692)

Event Date 01/24/2017

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 surgeon was about to begin a partial knee arthroplasty procedure using the robotic arm interactive orthopedic system (rio), when the system displayed a hall error during arm status check.The patient was already under anesthesia when the surgeon decided to cancel the case.

Manufacturer Narrative

Based on the results of investigation.Reported device: the reported device is a motor assy, j3, catalog # 207569, lot # rob401, rma# (b)(4).Device history review: the device history shows that the system that includes this component was manufactured and accepted into final stock on 1/28/2016.Device evaluation and results: gsp case (b)(4) states that the j3 hall error was confirmed.The motor assembly was replaced to correct the issue.Complaint history review: a review of complaints related to system rob401 related to the failure in this investigation shows one additional complaint: (b)(4).Conclusions: the system produced a hall error.The motor was replaced, which fixed the issue.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 surgeon was about to begin a partial knee arthroplasty procedure using the robotic arm interactive orthopedic system (rio), when the system displayed a hall error during arm status check.The patient was already under anesthesia when the surgeon decided to cancel the case.

• Brand Name: 3.0 RIO® ROBOTIC ARM - MICS
• Type of Device: STEREOTACTIC 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: michael mcavenia ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 6282606
• MDR Text Key: 65959891
• Report Number: 3005985723-2017-00041
• 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: 02/21/2017

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/24/2017
• Initial Date FDA Received: 01/27/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/21/2017
• 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): Hospitalization