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

Model Number 209063

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 11/07/2019

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

As reported: "mics handpiece failed causing cuts to be inaccurate after passing verification.This caused surgeon to cement the knee instead of pressfit." update 12/november/2019: as reported by the mps "when dr.Was trailing the femur component the cuts did not match up with the femur trial.Confirmed correct size.The patient had unusually hard bone so we decided to put the robot back in to go over all the cuts again to rule out blade skiving.When the surgeon put the green probe to the saw blade it was reading about 2.8mm off.I examined the vizi discs and saw attachment and found everything in order.I then tightened the robot base array and instructed the scrub tech to re-register the robot.We where able to pass building the box but verification failed two times in a row.There was no plastic under the mics that i could see.I instructed the surgeon that the robot is down and the only fix would be to get a new mics.He did not want to wait that long so he decided to clean the cuts as best he could with a manual saw and cement the components in.The original plan was to press fit.As the surgeon was working i placed the robot behind the operating table and tried to trouble shoot the mics registration myself.I had the same results as the scrub tech did.Upon disassembling the mics i found that an internal screw where the attachments go into had sheered off.The entire front of the mics also felt a bit loose.I documented this with a picture.A full investigation has been requested and session files and anonymous patient plan will be uploaded to the share drive per protocol.My assessment is that during the distal femur cut and/or the posterior chamfer cuts the mics broke without us knowing causing the cuts to be off." a surgical delay of over 30 minutes was reported.

Manufacturer Narrative

"reported issue.As reported: "mics handpiece failed causing cuts to be inaccurate after passing verification.This caused surgeon to cement the knee instead of press-fit." update 12/november/2019: as reported by the mps "when doctor was trialing the femur component the cuts did not match up with the femur trial.Confirmed correct size.The patient had unusually hard bone so we decided to put the robot back in to go over all the cuts again to rule out blade skiving.When the surgeon put the green probe to the saw blade it was reading about 2.8mm off.I examined the vizi discs and saw attachment and found everything in order.I then tightened the robot base array and instructed the scrub tech to re-register the robot.We were able to pass building the box but verification failed two times in a row.There was no plastic under the mics that i could see.I instructed the surgeon that the robot is down and the only fix would be to get a new mics.He did not want to wait that long so he decided to clean the cuts as best he could with a manual saw and cement the components in.The original plan was to press-fit.As the surgeon was working i placed the robot behind the operating table and tried to trouble shoot the mics registration myself.I had the same results as the scrub tech did.Upon disassembling the mics i found that an internal screw where the attachments go into had sheered off.The entire front of the mics also felt a bit loose.I documented this with a picture.A full investigation has been requested and session files and anonymous patient plan will be uploaded to the share drive per protocol.My assessment is that during the distal femur cut and/or the posterior chamfer cuts the mics broke without us knowing causing the cuts to be off." a surgical delay of over 30 minutes was reported.Product inspection: visual inspection of the handpiece confirmed that a shoulder screw that fixed the locking mechanism to the handpiece had sheared and the head of the screw was dissociated.Device history review: device history records indicate (b)(4)were manufactured under lot k06qd and were accepted into final stock on 3/22/16.No non-conformance was identified during inspection.Complaint history review: a review of complaints related to p/n 209063, lot 42010116 shows 03 additional complaints related to the failure in this investigation.(b)(4).Conclusion: the alleged failure mode was confirmed.No additional investigation or specific actions are required.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

As reported: "mics handpiece failed causing cuts to be inaccurate after passing verification.This caused surgeon to cement the knee instead of pressfit." update 12/november/2019: as reported by the mps "when dr.Was trialing the femur component the cuts did not match up with the femur trial.Confirmed correct size.The patient had unusually hard bone so we decided to put the robot back in to go over all the cuts again to rule out blade skiving.When the surgeon put the green probe to the saw blade it was reading about 2.8mm off.I examined the vizi discs and saw attachment and found everything in order.I then tightened the robot base array and instructed the scrub tech to re-register the robot.We where able to pass building the box but verification failed two times in a row.There was no plastic under the mics that i could see.I instructed the surgeon that the robot is down and the only fix would be to get a new mics.He did not want to wait that long so he decided to clean the cuts as best he could with a manual saw and cement the components in.The original plan was to press fit.As the surgeon was working i placed the robot behind the operating table and tried to trouble shoot the mics registration myself.I had the same results as the scrub tech did.Upon disassembling the mics i found that an internal screw where the attachments go into had sheered off.The entire front of the mics also felt a bit loose.I documented this with a picture.A full investigation has been requested and session files and anonymous patient plan will be uploaded to the share drive per protocol.My assessment is that during the distal femur cut and/or the posterior chamfer cuts the mics broke without us knowing causing the cuts to be off." a surgical delay of over 30 minutes was reported.

• 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: 9396932
• MDR Text Key: 189676148
• Report Number: 3005985723-2019-00879
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 03/11/2020

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: 42010116 / 4200443
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/08/2019
• Initial Date FDA Received: 12/02/2019
• Supplement Dates Manufacturer Received: 02/19/2020
• Supplement Dates FDA Received: 03/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization