MAUDE Adverse Event Report: MAKO SURGICAL CORP. HANDPIECE MICS; STEREOTAXIC DEVICE, ROBOTICS

Model Number 209063

Device Problems Electrical /Electronic Property Problem (1198); Output Problem (3005)

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

Event Date 09/11/2019

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

Mics status check passed, and rio setup and registration was fine.Once case started, at time of bone prep starting with saw, the trigger would not align the robot arm.We changed to the burr and same result.Cutter reset same result.Warning of "cable connection error in cutting system" was displaying.We opened a backup mics with the same result.I then did mics status check and that failed.We then used a backup rio system to rule it out.We opened a 3rd mics for the new system and completed the case successfully.After the case the original mako system 118 was rebooted, the mics duplicated the communication warning and mics status check failed.The 2nd mics tested fine with rob118 so the 1st mics was tagged bad.Case type: pka (mics).Surgical delay: =15 minutes.

Event Description

Mics status check passed, and rio setup and registration was fine.Once case started, at time of bone prep starting with saw, the trigger would not align the robot arm.We changed to the burr and same result.Cutter reset same result.Warning of "cable connection error in cutting system" was displaying.We opened a backup mics with the same result.I then did mics status check and that failed.We then used a backup rio system to rule it out.We opened a 3rd mics for the new system and completed the case successfully.After the case the original mako system 118 was rebooted, the mics duplicated the communication warning and mics status check failed.The 2nd mics tested fine with rob118 so the 1st mics was tagged bad.Case type: pka (mics) surgical delay: =15 minutes.

Manufacturer Narrative

Mics status check passed, and rio setup and registration was fine.Once case started, at time of bone prep starting with saw, the trigger would not align the robot arm.We changed to the burr and same result.Cutter reset same result.Warning of ""cable connection error in cutting system"" was displaying.We opened a backup mics with the same result.I then did mics status check and that failed.We then used a backup rio system to rule it out.We opened a 3rd mics for the new system and completed the case successfully.After the case the original mako system 118 was rebooted, the mics duplicated the communication warning and mics status check failed.The 2nd mics tested fine with rob118 so the 1st mics was tagged bad.Case type: pka (mics).Surgical delay: =15 minutes.Product inspection: mics-209063, sn#: (b)(6), rma#280111, lot 42020316.Inspected per d06917 and determined failure of the following test step.Sec# 7.1.2.Visual no power with new cable.Disposition: rtv device history review: review of device history records indicate (b)(4) devices were manufactured under lot k076w and all were accepted into final stock on 04/14/2016 with no reported discrepancies.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 209063, lot number 42020316 shows 2 additional complaints related to the failure in this investigation.Conclusion: the alleged failure mode was confirmed.No additional investigation or specific actions are required.¿ if additional information is received then the complaint will be reopened.

• Brand Name: HANDPIECE MICS
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9007947
• MDR Text Key: 157821197
• Report Number: 3005985723-2019-00672
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486030193
• UDI-Public: 00848486030193
• Combination Product (y/n): N
• PMA/PMN Number: K142530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/21/2020

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: 209063
• Device Catalogue Number: 209063
• Device Lot Number: 42020316 / 4200572
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2019
• Initial Date Manufacturer Received: 09/11/2019
• Initial Date FDA Received: 09/12/2019
• Supplement Dates Manufacturer Received: 12/25/2019
• Supplement Dates FDA Received: 01/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization