MAUDE Adverse Event Report: MAKO SURGICAL CORP. MOTOR ASSY, J3; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number 207569

Device Problems Mechanical Problem (1384); Output Problem (3005)

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

Event Date 08/13/2019

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

Case number: (b)(4), rob542 - mps (b)(6) reported error 24 and could not pass homing on m3.Case type: tka.Surgery was not completed robotically.Update: "yes, patient was involved.During approach mode, while aligning itself for the femur distal cut the saw blade made contact with the patient¿s distal femur.Surgeon noted that blade did make a mark on the patient¿s bone, however they did not consider it arm and that section of bone was removed during manual tka.Surgeon had already made his exposure and no cuts had been made with the robot, so when the robot failed a standard instrumented tka was preformed." approximately 20 min delay.

Manufacturer Narrative

Reported event: mps (b)(6) reported error 24 and could not pass homing on m3.Device evaluation and results: per wo-(b)(4): swapped the front and backside cards but the problem persisted.Replaced the j3 motor which corrected the problem.System investigation completed successfully as per service manual.All system checks and tests passed.Product history review a review of the device history records indicate 1 device was manufactured and accepted into final stock on 03/06/17.No non-conformances were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 207569 shows no additional complaints related to the failure in this investigation.Conclusions: system ready for clinical use.Corrective action/preventive action: no action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.

Event Description

Case number: (b)(4).Mps (b)(6) reported error 24 and could not pass homing on m3.Case type: tka.Surgery was not completed robotically.Update: "yes, patient was involved.During approach mode, while aligning itself for the femur distal cut the saw blade made contact with the patient¿s distal femur.Surgeon noted that blade did make a mark on the patient¿s bone, however they did not consider it arm and that section of bone was removed during manual tka.Surgeon had already made his exposure and no cuts had been made with the robot, so when the robot failed a standard instrumented tka was preformed " approximately 20 min delay.

• Brand Name: MOTOR ASSY, J3
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8946572
• MDR Text Key: 156172450
• Report Number: 3005985723-2019-00610
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• 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

• Date FDA Received: 08/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 207569
• Device Lot Number: NOT REPORTED
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization