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

Catalog Number 209999

Device Problems Material Integrity Problem (2978); Insufficient Information (3190)

Patient Problems Bone Fracture(s) (1870); No Known Impact Or Consequence To Patient (2692)

Event Date 10/17/2017

Event Type  Injury  

Manufacturer Narrative

As part of 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

During drilling of the in wound femoral pin (4x 140 pin) the distal anterior portion of the femur fractured.The tka was aborted.

Manufacturer Narrative

Follow-up #1 and final report submitted to update sections catalog #, based on the results of investigation.During drilling of the in wound femoral pin (4x 140 pin) the distal anterior portion of the femur fractured.The tka was aborted.The product was unavailable for inspection as the product was not returned.Unable to perform as the lot number was not provided.Unable to perform as the lot number was not provided.Product was unavailable for inspection and lot information unavailable for device history review.User manual identifies predrilling of hard bone may be required and sites publications which support the potential for risk of fracture near the bone pin sites.Based on users experience, this failure mode is a knowledge based error.A review of stryker¿s nc/capa database indicated there have been 0 ncs and capas associated with the product and failure mode reported in this event.Device not returned.

Event Description

During drilling of the in wound femoral pin (4x 140 pin) the distal anterior portion of the femur fractured.The tka was aborted.

• 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: 6957813
• MDR Text Key: 89586837
• Report Number: 3005985723-2017-00505
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• PMA/PMN Number: K143752
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 209999
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR