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 08/18/2019

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.As reported in pi # (b)(4): "dr.Performed an i&d with a tibial insert exchange of a mako left medial uni knee due to infection.Original surgery was (b)(6) 2019".Rep provided primary and revision usage sheets and reported that no further information is available from the hospital or surgeon.

Event Description

This pi is for the robot used in the primary procedure.As reported in pi # (b)(4): "dr.Performed an i&d with a tibial insert exchange of a mako left medial uni knee due to infection.Original surgery was (b)(6)2019".Rep provided primary and revision usage sheets and reported that no further information is available from the hospital or surgeon.

Manufacturer Narrative

Reported event: an event regarding infection involving 3.0 rio® robotic arm - mics, catalog: 209999 was reported.As reported in pi # (b)(4): "dr.Performed an i&d with a tibial insert exchange of a mako left medial uni knee due to infection.Original surgery was (b)(6)2019 ".Rep provided primary and revision usage sheets and reported that no further information is available from the hospital or surgeon.Product evaluation and results: not performed as case session data was not provided.Product history review review of the device history records was not completed as the robot number was not provided.Complaint history review a search of the complaint database under device identification pn 209999 reports no similar complaints for tka 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 pn 209999 reports no records related to tka software - other.H3 other text : device not returned.

• 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: 8946789
• MDR Text Key: 156027464
• Report Number: 3005985723-2019-00624
• 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: 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2019
• 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: 02/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 80 YR