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); Output Problem (3005)

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

Event Date 02/26/2019

Event Type  malfunction  

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

(b)(4) - reported by (b)(6) - mics turning on outside haptics.Application tka.Was the patient under anesthesia at the time of the issue? (yes/no): yes.Surgical delay: <15min.

Manufacturer Narrative

Follow-up #1 and final report submitted.Investigation conclusion: reported event: an event regarding the mics operating outside of stereotactic boundaries 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 202 found quality inspection procedures successfully passed.Complaint history: based on the device identification (pn 209999) the complaint databases were reviewed from 2011 to present for similar reported events regarding the mics operating outside of the stereotactic boundaries.There were no similar reported events for the listed catalog number.Conclusion: resolution per gsp 168943: 1.After hours of testing i could not duplicate the problems that were reported.I tested all mics ib the tka mode - they would not power on outside the haptics each time in rio setup mode in tka the arm was steady and did not droop.I replaced the anspach assy and pig tail cables for isolation purposes and continued testing without any issues.Parts replaced: 209780 anspach control assy qty-1.210459 burr detect cable qty-1.209403 anspach cable qty-1.All tesing and verifications passed.System is ready for clinical use.

Event Description

Rob202 - reported by (b)(6) - mics turning on outside haptics.Application tka.Was the patient under anesthesia at the time of the issue? (yes/no) yes.Surgical delay: <15min.

• 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: 8416230
• MDR Text Key: 138796055
• Report Number: 3005985723-2019-00223
• 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: 05/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 209999
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization