MAUDE Adverse Event Report: MAKO SURGICAL CORP. HANDPIECE MICS; STEREOTACTIC DEVICE

Catalog Number 209063

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 06/04/2018

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

Mics handpiece was unresponsive and failed mics status check.Surgeon completed balancing, when we brought the robot in to make cuts, the surgeon pulled the trigger to auto align mics, there was no response.We performed troubleshooting steps, to include resetting the cutter, still no response from the mics.We swapped the mics for a new one; performed a mics status check - mics failed.We performed additional troubleshooting and attempted the status check again, still failed.We swapped the mics out again, this time the mics passed checks and worked properly.Tka case delayed 5 minutes.After the surgery was completed; i performed a mics status checks on all six mics handpieces - four failed (including the two used in the surgery).

Event Description

Mics handpiece was unresponsive and failed mics status check.Surgeon completed balancing, when we brought the robot in to make cuts, the surgeon pulled the trigger to auto align mics, there was no response.We performed troubleshooting steps, to include resetting the cutter, still no response from the mics.We swapped the mics for a new one; performed a mics status check - mics failed.We performed additional troubleshooting and attempted the status check again, still failed.We swapped the mics out again, this time the mics passed checks and worked properly.(b)(4) case delayed 5 minutes.After the surgery was completed; i performed a mics status checks on all six mics handpieces - four failed (including the two used in the surgery).

Manufacturer Narrative

Follow-up #1 and final report submitted.Reported issue: mics handpiece was unresponsive and failed mics status check.Surgeon completed balancing, when we brought the robot in to make cuts, the surgeon pulled the trigger to auto align mics, there was no response.We performed troubleshooting steps, to include resetting the cutter, still no response from the mics.We swapped the mics for a new one; performed a mics status check - mics failed.We performed additional troubleshooting and attempted the status check again, still failed.We swapped the mics out again, this time the mics passed checks and worked properly.(b)(4) case delayed 5 minutes.After the surgery was completed; i performed a mics status checks on all six mics handpieces - four failed (including the two used in the surgery).Product history review: device history records indicate (b)(4) devices were manufactured under lot k09q5 and (b)(4) were accepted into final stock on 05/30/2017.Complaint history review: a review of complaints related to p/n 209063, s/n (b)(4) in prodex lot k09q5 shows 2 additional complaint(s) related to the failure in this investigation.Complaint pr: (b)(4).Visual inspection: visual inspection revealed no physical damage of unit.Dimensional inspection: dimensional inspection was not completed.Reported problem was a functional issue.Material analysis: material analysis was not completed because the failure was functional.Functional inspection: the handpiece was tested in the handpiece test (qip0243) and failed.The motor did not spin during the test.Screenshot is attached.Conclusion: the handpiece driver electronics (commutation board) communicates with the handpiece trigger.A failure of this communication will break the process that allows the trigger command to result in the motor spinning.

• Brand Name: HANDPIECE MICS
• Type of Device: STEREOTACTIC DEVICE
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 7651869
• MDR Text Key: 112791680
• Report Number: 3005985723-2018-00386
• 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: 09/05/2018

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 Catalogue Number: 209063
• Device Lot Number: 4202194 / 42010517
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/04/2018
• Initial Date FDA Received: 06/29/2018
• Supplement Dates Manufacturer Received: 08/30/2018
• Supplement Dates FDA Received: 09/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other