MAUDE Adverse Event Report: MAKO SURGICAL CORP. J6 ARM FOR HIP WITH QD; STEROTAXIC DEVICE

Catalog Number 203477

Device Problems Electrical /Electronic Property Problem (1198); Device Displays Incorrect Message (2591); Positioning Problem (3009)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 03/18/2015

Event Type  malfunction  

Event Description

The surgeon performed a total hip arthroplasty using the robotic arm interactive orthopedic system (rio).Towards the end of the case, the rio arm experienced joint angle inconsistency errors.The resulting outcome of the case was successful and there was no harm to patient.

Manufacturer Narrative

As part of normal complaint follow-up, an evaluation of the event has been initiated at mako surgical.A mako field service engineer conducted on-site testing of the rio and was able to confirm the alleged failure of the robotic arm.The issue was resolved.A supplemental report will be filed if additional information is obtained in the future.

Manufacturer Narrative

Reported event: an event regarding a disconnected encoder glass involving a j6 arm on a rio 2.2 ((b)(4)) was reported.The event was confirmed.Method & results: device evaluation and results: a functional evaluation of the j6 arm was completed.The cause of the intermittent encoder signal was an encoder glass that had come loose.Medical records received and evaluation: no medical review was completed.Device history review: review of the device history records indicate (b)(4) device was manufactured and accepted into final stock on 06/11/2014.Complaint history review: a review of complaints related to rob285 shows no other complaints related to the failure in this investigation.Conclusions: the investigation concluded that the intermittent encoder signal was caused by an encoder glass that had come loose.The j6 arm was replaced in the field and the rio was returned to proper service after tests were completed.

Event Description

The surgeon performed a total hip arthroplasty using the robotic arm interactive orthopedic system (rio).Towards the end of the case, the rio arm experienced joint angle inconsistency errors.The resulting outcome of the case was successful and there was no harm to patient.

• Brand Name: J6 ARM FOR HIP WITH QD
• Type of Device: STEROTAXIC DEVICE
• 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: jonathan reeves ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 4760099
• MDR Text Key: 5954024
• Report Number: 3005985723-2015-00069
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/17/2015

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: Other
• Device Catalogue Number: 203477
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/17/2015
• Initial Date FDA Received: 05/08/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/07/2015
• 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): Required Intervention