MAUDE Adverse Event Report: MAKO SURGICAL CORP. CART- GUIDANCE MODULE; STEREOTACTIC DEVICE, ROBOTICS

Catalog Number 207577

Device Problems Device Displays Incorrect Message (2591); Connection Problem (2900)

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

Event Date 12/28/2016

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).The mps reported j6 index error during hip impaction.

Manufacturer Narrative

Device identification: the reported device was confirmed to be a 3.0 rio® robotic arm - mics, p/n 209999, lot rob069.Device history review: a dhr review shows that the robot that includes this component was assembled and released to inventory on 08/05/2009.Preventive maintenance was most recently successfully completed on 10/24/2016.Device evaluation and results: according to gsp case (b)(4), the fse confirmed the failures in the system logs.However, the failure could not be reproduced.Complaint history review: a review of complaints on rob069 shows no additional complaints related to the failure in this investigation.Conclusions: the error was confirmed in the system logs.However, the failure could not be reproduced.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).The mps reported j6 index error during hip impaction.

• Brand Name: CART- GUIDANCE MODULE
• 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: 6281187
• MDR Text Key: 65905299
• Report Number: 3005985723-2017-00039
• 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: 02/01/2017

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: 207577
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/28/2016
• Initial Date FDA Received: 01/26/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/01/2017
• 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