MAUDE Adverse Event Report: MAKO SURGICAL CORP. RIO SURGICAL ARM; STEREOTACTIC DEVICE, ROBOTICS

Catalog Number 203999

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

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

Event Date 12/14/2016

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 (rio) when an encoder error occurred.The surgeon was able to finish the case manually.

Manufacturer Narrative

Reported event: the reported device was confirmed to be a j6 arm for hip with qd, p/n 207557, lot ro287.Device history review: review of the device history records indicates rob287, which includes the j6 segment, was manufactured and accepted into final stock on 06/23/2014.Device evaluation and results: according to gsp case (b)(4), the fse determined that the j6 encoder had delaminated from the hub.Complaint history review: a review of complaints related to the j6 arm shows 10 additional complaints since january 2015 related to the failure in this investigation.Conclusions: the failure was confirmed by the fse.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 completing a total hip arthroplasty procedure using the robotic arm interactive orthopedic system (rio) when an encoder error occurred.The surgeon was able to finish the case manually.

• Brand Name: RIO SURGICAL ARM
• 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: 6185101
• MDR Text Key: 62706623
• Report Number: 3005985723-2016-00442
• 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: 01/31/2017

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: 203999
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/15/2016
• Initial Date FDA Received: 12/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/31/2017
• 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