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

Catalog Number 209999

Device Problems Device Displays Incorrect Message (2591); Insufficient Information (3190)

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

Event Date 02/14/2017

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.During cup impaction sequence, as the surgeon was impacting the cup into the acetabulum the image on the screen would show the implant misaligned with the acetabulum and received a message prompt that indicated ¿joint angles inconsistent error----call service¿ this occurred at the exact same time during both cases.Both case were completed manually.

Manufacturer Narrative

Reported event: the reported device was confirmed to be a 3.0 rio robotic arm - mics, catalog # 209999, serial# (b)(4).Mps reported angle inconsistency error occured.Device history: a review of the device history records shows that (b)(4) was built and passed all its qip tests as signified by the quality signature on november 14, 2016.Device inspection: a review of the crisis logs confirms that " joint angles inconsistent error (j6) " occurred as reported.Per (b)(4) the errors could not be duplicated.The system was tested and returned to customer.Complaint history: a review of complaints related to p/n 209999, (b)(4) shows one other complaint related to the failure in this investigation; the complaint is trackwise (b)(4).Conclusion: the report of a joint angles inconsistent error on 3.0 rio robotic arm - mics, catalog # 209999, serial# (b)(4) was confirmed but not duplicated.The error occurred during a case and resulted in a conversion to manual.Further action: no further action is required at this time.

Event Description

The surgeon was completing a total hip arthroplasty procedure using the robotic arm interactive orthopedic system.During cup impaction sequence, as the surgeon was impacting the cup into the acetabulum the image on the screen would show the implant misaligned with the acetabulum and received a message prompt that indicated ¿joint angles inconsistent error----call service¿ this occurred at the exact same time during both cases.Both case were completed manually.

• 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: 6342851
• MDR Text Key: 67846988
• Report Number: 3005985723-2017-00078
• 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: 05/08/2017

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: 02/14/2017
• Initial Date FDA Received: 02/20/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/08/2017
• 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