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

Model Number 209999

Device Problems Computer Software Problem (1112); Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 07/09/2019

Event Type  Injury  

Manufacturer Narrative

As part of the 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

This pi is for the robot used in the primary procedure: "dr.(b)(6) performed an i&d with poly exchange on a mako medial uni knee originally done on (b)(6) 2019 due to infection.No issues with the component was found".

Event Description

This pi is for the robot used in the primary procedure: "dr.(b)(6) performed an i&d with poly exchange on a mako medial uni knee originally done on (b)(6) 2019 due to infection.No issues with the component was found".

Manufacturer Narrative

Reported event: an event regarding infection involving 3.0 rio® robotic arm - mics, catalog: 209999 was reported.It was reported that the ¿dr.(b)(6) performed an i&d with poly exchange on a mako medial uni knee originally done on (b)(6) 2019 due to infection.No issues with the component was found.¿ product evaluation and results: product inspection could not be performed because no further information will be released by the hospital or surgeon.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records associated with rio 163 indicate quality inspection procedures were completed with no reported discrepancies.Complaint history review: a search of the complaint database under device identification pn 209999 reports no similar complaints for pka software - other.Conclusions: the failure could not be determined as no case session data or logs were provided after three communication attempts were made.No additional investigation or specific actions are required at this time.If additional information is received such as the session files, then the complaint will be reopened.Corrective action/preventive action: a search of the nc/capa database under device identification (b)(4) reports no records related to pka software - other.

• 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
• MDR Report Key: 8814500
• MDR Text Key: 151840255
• Report Number: 3005985723-2019-00523
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486030407
• UDI-Public: 00848486030407
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 209999
• Device Catalogue Number: 209999
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 73 YR