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

Model Number 209999

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 10/30/2019

Event Type  malfunction  

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.(b)(6) revised a triathlon insert due to possible infection.He performed an i&d.Original surgery was mako on (b)(6) 2019.Update 30/october/2019 wg: rep provided primary and revision usage sheets.No further information is available due to hospital policy." update 31/october/2019 wg: rep reported that he was the acting mps for the primary procedure, and the login/ session files from that primary date are not available.

Manufacturer Narrative

Reported event: an event regarding revision due to possible infection involving 3.0 rio® robotic arm - mics, catalog: 209999 was reported.It was reported that "dr.(b)(6) revised a triathlon insert due to possible infection.He performed an i&d.Original surgery was mako on (b)(6) 2019.Update 30/october/2019 wg: rep provided primary and revision usage sheets.No further information is available due to hospital policy.Update 31/october/2019 wg: rep reported that he was the acting mps for the primary procedure, and the login/ session files from that primary date are not available.¿ product evaluation and results: not performed as case session data was not provided.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 tka software - other.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Additional information including device details, operative reports, progress notes, x-rays, return of the device and case session data/logs are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.Corrective action/preventive action: a search of the nc/capa database under device identification pn 209999 reports no records related to tka software - other.

Event Description

This pi is for the robot used in the primary procedure.As reported in (b)(4): "dr.(b)(6) revised a triathlon insert due to possible infection.He performed an i&d.Original surgery was mako on (b)(6) 2019.Update 30/october/2019 wg: rep provided primary and revision usage sheets.No further information is available due to hospital policy." update 31/october/2019 wg: rep reported that he was the acting mps for the primary procedure, and the login/ session files from that primary date are not available.

• 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: 9378976
• MDR Text Key: 182178268
• Report Number: 3005985723-2019-00858
• 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: 04/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2019
• 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: 03/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other