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

Model Number 209999

Device Problems Output Problem (3005); Insufficient Information (3190)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 10/24/2019

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.Pt fractured their femur post-op and want to run the workflow.I believe the pt fractured their femur during physical therapy/during a fall.Patient plan and log files: (b)(6).Case type: tka.

Event Description

This pi is for the robot used in the primary procedure.Pt fractured their femur post-op and want to run the workflow.I believe the pt fractured their femur during physical therapy/during a fall patient plan and log files: (b)(6).Case type: tka.

Manufacturer Narrative

Reported event: an event regarding periprosthetic fracture involving 3.0 rio® robotic arm - mics, catalog: 209999 was reported.It was reported that ¿pt fractured their femur post-op and want to run the workflow.I believe the pt fractured their femur during physical therapy/during a fall¿ product evaluation and results: review of the case session files was not performed as case session data was not provided.-clinician review: not performed as no medical records were provided for review.Product history review review of the device history records associated with rio 857 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 tha 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 tha 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: 9260157
• MDR Text Key: 164424180
• Report Number: 3005985723-2019-00785
• 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: company representative
• Type of Report: Initial,Followup
• Report Date: 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• 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: 04/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other