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

Catalog Number 207557

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 10/21/2016

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

While the surgeon was performing a partial knee arthroplasty procedure using the robotic arm interactive orthopedic system (rio), the robotic arm locked up and an error popped up.

Manufacturer Narrative

Reported event: the reported device is a 3.0 rio® robotic arm - mics, catalog #: 209999, serial #: (b)(4).Joint angles inconsistency error occured.Device history review: a review of the dhr associated with (b)(4) found that joint tests all passed successfully.All nprs opened were not relevant to the problem observed here and have been closed.Device inspection: per gsp:137733.J6 encoder wheel became delaminated.Replace j6 arm.Complaint history review: based on the device identification, the catsweb and trackwise complaint databases were reviewed from 2011 to present for similar reported events regarding the 3.0 rio® robotic arm - mics.There have been no other events for the referenced serial number.Conclusion: midway though the case the robot gave a joint angle inconsistency error for j6.The case was postponed until an fse came to repair.An encoder wheel had become delaminated and j6 required replacing.The case was finished the following morning.Further action: no further action required.

Event Description

While the surgeon was performing a partial knee arthroplasty procedure using the robotic arm interactive orthopedic system (rio), the robotic arm locked up and an error popped up.

Manufacturer Narrative

Reported event: the reported device is a 3.0 rio® robotic arm - mics, catalog #: 209999, serial #: (b)(4).Joint angles inconsistency error occured.Device history review: a review of the dhr associated with (b)(4) found that joint tests all passed successfully.All nprs opened were not relevant to the problem observed here and have been closed.Device inspection: per gsp:(b)(4), j6 encoder wheel became delaminated, replace j6 arm.Complaint history review: based on the device identification, the catsweb and trackwise complaint databases were reviewed from 2011 to present for similar reported events regarding the 3.0 rio® robotic arm - mics.There have been no other events for the referenced serial number.Conclusion: midway though the case the robot gave a joint angle inconsistency error for j6.The case was postponed until an fse came to repair.An encoder wheel had become delaminated and j6 required replacing.The case was finished the following morning.Further action: no further action required.

Event Description

While the surgeon was performing a partial knee arthroplasty procedure using the robotic arm interactive orthopedic system (rio), the robotic arm locked up and an error popped up.

• Brand Name: J6 ARM FOR HIP WITH QD
• 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: 6080800
• MDR Text Key: 59224799
• Report Number: 3005985723-2016-00363
• 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,Followup
• Report Date: 02/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 207557
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/22/2017
• 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