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

Model Number 209063

Device Problems Difficult or Delayed Positioning (1157); Noise, Audible (3273)

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

Event Date 01/13/2020

Event Type  malfunction  

Manufacturer Narrative

As part of normal complaint follow-up, an evaluation of the event has been initiated by mako surgical.A supplement al report will be submitted when additional information becomes available.

Event Description

We had just pushed the robot in to start cuts on our tka.Dr (b)(6) pulled the trigger to take the robot into the cutting plane and he pulled the trigger the second time to start the saw and cut.The robotic arm started shaking and making a very loud grounding sound.It has never done this before.We had passed all pre surgery checks that morning without difficulty.The mics status check passed as well.At this point we did another arm status check and it passed.We noticed that some of the screws by joint 6 on the robot cover were lose.We tightened them.Made sure mics was tight.Re did robot registration.We then tried to re- position the robot to see if it was cutting plane issue.The same sound and vibration continued.I then called mako support.The issued a service call and we discussed doing hard shut down and home etc.The scrub tech then when to take the saw attachment back out and the mics hand piece was difficult to turn and remove the attachment.So we decided to start from the beginning.I did a hard shut down.Arm check, home, and brake check.Re draped and put on a new mics.Did robot registration.We went back into bone prep.Dr (b)(6) was able to get into cutting zone.The arm was no longer making this sound and the shaking of the arm stopped.We were able to complete the case without difficulty.No patient harm.I did receive a call from my fse.We discussed what took place and he was planning on checking things out today.Case type: tka.Surgical delay: x > 30 minutes.

Manufacturer Narrative

"reported issue: we had just pushed the robot in to start cuts on our tka.Dr douglas pulled the trigger to take the robot into the cutting plane and he pulled the trigger the second time to start the saw and cut.The robotic arm started shaking and making a very loud grounding sound.It has never done this before.We had passed all pre surgery checks that morning without difficulty.The mics status check passed as well.At this point we did another arm status check and it passed.We noticed that some of the screws by joint 6 on the robot cover were lose.We tightened them.Made sure mics was tight.Re did robot registration.We then tried to re- position the robot to see if it was cutting plane issue.The same sound and vibration continued.I then called mako support.The issued a service call and we discussed doing hard shut down and home etc.The scrub tech then when to take the saw attachment back out and the mics hand piece was difficult to turn and remove the attachment.So we decided to start from the beginning.I did a hard shut down.Arm check, home, and brake check.Re draped and put on a new mics.Did robot registration.We went back into bone prep.The doctor was able to get into cutting zone.The arm was no longer making this sound and the shaking of the arm stopped.We were able to complete the case without difficulty.No patient harm.I did receive a call from my fse.We discussed what took place and he was planning on checking things out today.Case type: tka.Surgical delay: x > 30 minutes.Product inspection: original description confirmed.Failed due to collar issue.(b)(4), sn#: (b)(6), rma#: (b)(4), lot#42021015.Inspected per d06917 and determined failure of the following test step.Sec# 7.1.4.Collar test.Bearings tight and won¿t open to allow registration tool to enter.Disposition: rtv inspected by: (b)(4).Device history review: device history records indicate (b)(4) devices were manufactured under prodex lot k0670 and 23 were accepted into final stock on 10/24/2015.A review of qt15-10-0069 and qt15-10-0070 revealed that the issues are 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 number42021015 shows no 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.Nc/capa review: a review of stryker¿s nc/capa database indicated there have been no nc and capa associated with the product and failure mode reported in this event.

Event Description

We had just pushed the robot in to start cuts on our tka.Dr douglas pulled the trigger to take the robot into the cutting plane and he pulled the trigger the second time to start the saw and cut.The robotic arm started shaking and making a very loud grounding sound.It has never done this before.We had passed all pre surgery checks that morning without difficulty.The mics status check passed as well.At this point we did another arm status check and it passed.We noticed that some of the screws by joint 6 on the robot cover were lose.We tightened them.Made sure mics was tight.Re did robot registration.We then tried to re- position the robot to see if it was cutting plane issue.The same sound and vibration continued.I then called mako support.The issued a service call and we discussed doing hard shut down and home etc.The scrub tech then when to take the saw attachment back out and the mics hand piece was difficult to turn and remove the attachment.So we decided to start from the beginning.I did a hard shut down.Arm check, home, and brake check.Re draped and put on a new mics.Did robot registration.We went back into bone prep.Dr douglas was able to get into cutting zone.The arm was no longer making this sound and the shaking of the arm stopped.We were able to complete the case without difficulty.No patient harm.I did receive a call from my fse.We discussed what took place and he was planning on checking things out today.Case type: tka.Surgical delay: x > 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: 9663248
• MDR Text Key: 177542869
• Report Number: 3005985723-2020-00071
• 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: 04/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2020
• 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: 42021015 / 4200257
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 71 YR