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

Catalog Number 209063

Device Problems Electrical Power Problem (2925); Output Problem (3005)

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

Event Date 05/14/2019

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

This is the first pi (3rd case) of two.".In the third case we were using a newly refurbished mics that had just been put into circulation at the account and when we aligned it up to the plane of cut it went into haptics then as we tried to actually cut we had no power.We shut down the robot, waited 60 seconds, switched out the mics, turned it back on, homed it, then did a mics status check that failed again.We tried a third mics going through the same process and this one passed mics status so we finished that case robotically.However we got to the fourth case and did a mics status check as we were setting up and the pt was getting under anesthesia.The mics status check failed even though it was the same mics we had used in the first case with no issues.We attempted the last sterile mics we had available and it failed as well so we had to convert to a manual tka.So we had 4 mics out of our 6 fail mics status today alone while 2 of them were brand new refurbished ones and one had only been used once the week prior.Since this is a continuing issue our fse is requesting the replacements be new mics and not refurbished ones to help eliminate the issues we are facing.Our next case is next tuesday but i will need to do a mics status check prior to them going into circulation to make the account more comfortable in proceeding with the robot.Case type: tka.Surgical delay: approx.16-30 minutes.

Manufacturer Narrative

Reported issue.It was reported that the mics had power failure during the case product inspection: as per service (b)(4) & case number (b)(4).Handle screw missing.The alleged failure was not confirmed.Device history review: device history records indicate 25 devices were manufactured under lot k0aeq and 24 devices were accepted into final stock on 11/04/2017.A review of qt17- 11-0007 revealed that the issue is not related to the failure alleged in this compliant.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 209063, lot number 42041017 shows 4 additional complaints related to the failure in this investigation.The complaints are (b)(4).Conclusion: the failure was not confirmed.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.Nc/capa review: a review of stryker¿s nc/capa database indicated there have been an nc and capa associated with the product and failure mode reported in this event.This is nc 1414517 and capa 1450904.".

Event Description

This is the first pi (3rd case) of two.".In the third case we were using a newly refurbished mics that had just been put into circulation at the account and when we aligned it up to the plane of cut it went into haptics then as we tried to actually cut we had no power.We shut down the robot, waited 60 seconds, switched out the mics, turned it back on, homed it, then did a mics status check that failed again.We tried a third mics going through the same process and this one passed mics status so we finished that case robotically.However we got to the fourth case and did a mics status check as we were setting up and the pt was getting under anesthesia.The mics status check failed even though it was the same mics we had used in the first case with no issues.We attempted the last sterile mics we had available and it failed as well so we had to convert to a manual tka.So we had 4 mics out of our 6 fail mics status today alone while 2 of them were brand new refurbished ones and one had only been used once the week prior.Since this is a continuing issue our fse is requesting the replacements be new mics and not refurbished ones to help eliminate the issues we are facing.Our next case is next tuesday but i will need to do a mics status check prior to them going into circulation to make the account more comfortable in proceeding with the robot.Case type: tka.Surgical delay.Approx.16-30 minutes.

• 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: 8639932
• MDR Text Key: 146369794
• Report Number: 3005985723-2019-00383
• 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: 10/21/2019

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: 42041017/4203030
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/14/2019
• Initial Date FDA Received: 05/24/2019
• Supplement Dates Manufacturer Received: 10/13/2019
• Supplement Dates FDA Received: 10/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization