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

Catalog Number 209999

Device Problems Device Operates Differently Than Expected (2913); Insufficient Information (3190)

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

Event Date 02/28/2017

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 completing a total hip arthroplasty procedure using the robotic arm interactive orthopedic system.The arm was locking up during the surgery.The case was converted to manual.

Manufacturer Narrative

Reported event: the reported device was confirmed to be a 3.0 rio® robotic arm - mics, catalog# 209999, serial# rob285 which locked up during a case.Device history review: a review of the device history records shows that rob285 was built and its qips successfully completed as signified by the quality signature on june 16, 2014.Device evaluation and results: per gsp case# (b)(4).-arm locking up verified.-replaced j1 encoder read-head.-verified system is operating within mako tolerances and specifications.-system is ready for clinical use.Complaint history review: based on the device identification (pn 209999), serial # (b)(4) the complaint databases were reviewed from 2011 to present for similar reported events regarding connection issues.No similar events have been reported for the referenced serial number.Conclusions: the locking up of the arm was confirmed.The issue occurred during a case and resulted in a 3 minute delay and conversion to manual.The issue was cause by a faulty j1 encoder readhead which was replaced during the repair.The failure is attributed to normal wear.Corrective action/preventive action: no further action is required.

Event Description

The surgeon was completing a total hip arthroplasty procedure using the robotic arm interactive orthopedic system.The arm was locking up during the surgery.The case was converted to manual.

• 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: michael mcavenia ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 6484910
• MDR Text Key: 72510415
• Report Number: 3005985723-2017-00173
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141989
• 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: 05/11/2017

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: 02/28/2017
• Initial Date FDA Received: 04/12/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/11/2017
• 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