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 Result or Readings (1535); Output Problem (3005)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/27/2019

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

Impactions for two hips were both 5mm proud while surgeon confirmed they were down.Requested to have it investigated.Case type: tha.This complaint is the second of two.Please refer to pi (b)(4) for the first complaint.

Event Description

Impactions for two hips were both 5mm proud while surgeon confirmed they were down.Requested to have it investigated.Case type: tha this complaint is the second of two.Please refer to (b)(4) for the first complaint.

Manufacturer Narrative

Reported event: an event regarding a software error due to the system showing the cup was sitting proud involving 3.0 rio® robotic arm - mics, catalog: 209999 was reported.It was reported that ¿impactions for two hips were both 5mm proud while surgeon confirmed they were down.Requested to have it investigated.¿ 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 037 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 similar complaints for tha software - software error.The complaint record numbers are: 2060685, 2106015, 2110762, 2203820 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 - software error.

• 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: 9187115
• MDR Text Key: 175450108
• Report Number: 3005985723-2019-00731
• 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: 05/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 209999
• Device Catalogue Number: 209999
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/27/2019
• Initial Date FDA Received: 10/14/2019
• Supplement Dates Manufacturer Received: 03/07/2020
• Supplement Dates FDA Received: 05/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other