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 09/19/2019

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

Trials and implants did not appear to be fully seated and cuts (specifically anterior chamfer) appeared to be off.Case type: tka.Update: the only cut that was inaccurate to my knowledge was anterior chamfer.Cuts appeared to be deep.About 2mm discrepancy.Planar probe was utilized on distal and anterior cuts to find cuts were within range.Post op x rays not available.Patient had poor bone quality most likely resulting deep anterior chamfer cut.My goal in this is to rule out a robotic issue.No more pt information available.

Event Description

Trials and implants did not appear to be fully seated and cuts (specifically anterior chamfer) appeared to be off.Case type: tka.Update: the only cut that was inaccurate to my knowledge was anterior chamfer.Cuts appeared to be deep.About 2mm discrepancy.Planar probe was utilized on distal and anterior cuts to find cuts were within range.Post op x rays not available.Patient had poor bone quality most likely resulting deep anterior chamfer cut.My goal in this is to rule out a robotic issue.No more pt information available.

Manufacturer Narrative

Reported event: an event regarding a inaccurate resection involving 3.0 rio® robotic arm - mics, catalog: 209999 was reported.It was reported that ¿trials and implants did not appear to be fully seated and cuts (specifically anterior chamfer) appeared to be off.¿ it was also reported through a received customer contact that " the only cut that was inaccurate to my knowledge was anterior chamfer.Cuts appeared to be deep.About 2mm discrepancy.Planar probe was utilized on distal and anterior cuts to find cuts were within range.Post op x rays not available.Patient had poor bone quality most likely resulting deep anterior chamfer cut.My goal in this is to rule out a robotic issue.No more patient information available." 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 750 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 tka software - inaccurate resection.The complaint record numbers are: (b)(4).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 tka software - inaccurate resection.

• 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: 9196382
• MDR Text Key: 167353989
• Report Number: 3005985723-2019-00743
• 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: 04/01/2020

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?: No
• Initial Date Manufacturer Received: 09/19/2019
• Initial Date FDA Received: 10/16/2019
• Supplement Dates Manufacturer Received: 03/19/2020
• Supplement Dates FDA Received: 04/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization