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

Catalog Number 209999

Device Problems Computer Software Problem (1112); Non Reproducible Results (4029)

Patient Problem Bone Fracture(s) (1870)

Event Date 09/28/2018

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

Surgeon was impacting cemented tibial universal implant when tibia vertically split open.Surgical delay - > 60 minutes.Case type: tka.

Manufacturer Narrative

Reported event: an event regarding a damaged tibia during baseplate impaction during a total knee procedure involving 3.0 rio robotic arm - mics, catalog: 209999 was reported.Method & results: -device history review: a review of the dhr associated with rio 547 found quality inspection procedures successfully passed.-complaint history: based on the device identification (pn (b)(4) the complaint databases were reviewed from 2011 to present for similar reported events regarding damaged tibia during baseplate impaction.There were no other reported events for the listed catalog number.-conclusion: product inspection could not be completed because patient x-rays for use in a medical assessment could not be provided by the sales representative to complete the investigation.

Event Description

Surgeon was impacting cemented tibial universal implant when tibia vertically split open.Surgical delay - > 60 minutes case type: tka.

• 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: 7925517
• MDR Text Key: 122312680
• Report Number: 3005985723-2018-00565
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486030407
• UDI-Public: 00848486030407
• Combination Product (y/n): N
• PMA/PMN Number: K170581
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2018
• 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: 01/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other