MAUDE Adverse Event Report: MAKO SURGICAL ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-RIO; STEREOTAXIC DEVICE, ACCESSORY

Model Number 110940

Device Problem Environmental Particulates (2930)

Patient Problem Not Applicable (3189)

Event Date 08/08/2014

Event Type  malfunction  

Event Description

The product support specialist was performing a burr check on the anspach motor used with the robotic arm interactive orthopedic system (rio) to perform partial knee replacement with the restoris multicompartmental knee (mck) implant system.The anspach motor made a loud noise, overheated, and smoked a few minutes into the test.The motor passed the test, but did not reach maximum speed.

Manufacturer Narrative

As part of normal complaint follow-up, an evaluation of the event has been identified at mako surgical.The motor is being returned to mako surgical corp.From overseas and has not yet been received.A supplemental report will be submitted when results are obtained.

Manufacturer Narrative

The following is a supplemental report to the original mdr submitted previously.Additional information regarding the event is provided herein.The returned device was inspected upon receipt from the field.It was confirmed that the when the anspach motor was activated via foot pedal, the motor was loud and the rpm ranged varied from 72-75k (typically 80k rpm).After a minute, the anspach motor gets hots and smokes.The most probable cause of the observed symptom is bearing wear inside the burr motor.

• Brand Name: ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-RIO
• Type of Device: STEREOTAXIC DEVICE, ACCESSORY
• Manufacturer (Section D): MAKO SURGICAL; ft. lauderdale FL
• Manufacturer Contact: william tapia ; 2555 davie rd., ; ft. lauderdale, FL 33317 ; 9546280605
• MDR Report Key: 4084728
• MDR Text Key: 4824789
• Report Number: 3005985723-2014-00122
• 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: Health Professional,Company Representative,company representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 08/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 110940
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/08/2014
• 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
• Treatment: IMPLANT SYSTEM