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

Model Number 209999

Device Problems Incorrect, Inadequate or Imprecise Resultor Readings (1535); Output Problem (3005)

Patient Problems Tissue Damage (2104); Injury (2348)

Event Date 08/14/2019

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

Case was proceeding as normal. Robot operating as normal. Surgeon trialed and was happy with results. Arrays and pins were taken off of the patient. Surgeon chose to cement. 4 femur, 4 tibia, 9 poly insert. Cement was applied to implants and implants were put on patient, including cs poly. Surgeon cleaned up cement around implants using various tools. Surgeon let down the turnicate and pulled leg into extension and a pool of blood formed. This is when it was noticed that an artery was nicked. Polyethylene insert was taken out. Bleeding stopped when leg was in flexion, but continues when pulled into extension. Doppler used to check pulse on ankle. Call made to a vascular surgeon to come in and assess. Awaiting outcome. Case type: tka. Surgical delay: 30-60 minutes.

• 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
• Manufacturer (Section G): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer Contact: daniela davila ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 8928825
• MDR Text Key: 155497518
• Report Number: 3005985723-2019-00600
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative

Reporter Occupation

• 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: 08/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 209999
• Device Catalogue Number: 209999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/28/2020
• 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 Treatment Data

Date Received: 08/25/2019 Patient Sequence Number: 1