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

Catalog Number 209999

Device Problems Failure to Read Input Signal (1581); Device Operates Differently Than Expected (2913)

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

Event Date 02/04/2016

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 performed a makoplasty total hip arthroplasty using the robotic arm interactive orthopedic system (rio).During registering of the robot for reaming.The rio checkpoint failed and then multiple rio re-registration attempts failed as well.The surgery was completed using manual instruments.The case was successful and there was no harm to the patient.

Manufacturer Narrative

Reported event: an event regarding a failed reamer verification checkpoint involving 3.0 rio® robotic arm - mics, catalog: 209999 was reported.Method & results: device history review: a review of the dhr associated with rio 355 found quality inspection procedures successfully passed.Complaint history: based on the device identification (pn 209999) the complaint databases were reviewed from 2011 to present for similar reported events regarding failed rio registration.There were several other reported events.Conclusion: according to gsp case (b)(4), the fse noted the following: "while inspecting the system, i found debris on the j6 encoder glass and adjusted the read head for optimal signal strength.It was found barley passing.I performed kincal as well as an 8 cycle field hass with passing results.System ran for 6 hrs straight during testing without issue.Arm accuracy is great at.058mm for the lft and.041mm for the rht.Pm was also completed without issue.I did find in the logs that there were multiple j5 and j6 high torque warnings during the past few cases.This indicates that the dr¿s are being a bit aggressive during impaction and reaming.Also j2 bumpstops were knocked out of position.System is ready for clinical use.".

Event Description

The surgeon performed a makoplasty total hip arthroplasty using the robotic arm interactive orthopedic system (rio).During registering of the robot for reaming.The rio checkpoint failed and then multiple rio re-registration attempts failed as well.The surgery was completed using manual instruments.The case was successful and there was no harm to the patient.

• Brand Name: 3.0 RIO® ROBOTIC ARM - MICS
• Type of Device: STEREOTACTIC DEVICE, ROBOTIC
• 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: 5442513
• MDR Text Key: 38410754
• Report Number: 3005985723-2016-00061
• 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: 02/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 209999
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/04/2016
• 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): Other