MAUDE Adverse Event Report: MAKO SURGICAL CORP. MAKO ROBOTIC ARM 3.1; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 219999

Device Problems Unintended System Motion (1430); Application Program Problem: Parameter Calculation Error (1449); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/28/2022

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.Device not returned.

Event Description

Mps reported inaccurate tka cuts + usb hub on gud not working + camera drooping.In the last 3 tka cases, all cuts made with the angled sawblade attachment (distal femur and posterior chamfer) were consistently deep by 1-2mm.Surgeon makes the angled sawblade cuts last.Mps confirmed that all pre-surgery checks passed along with the femur checkpoint and sawblade checkpoint prior to 'bone preparation'.Those tka cases varied between left and right operative sides, varus v valgus, etc.Despite being deep by 1-2mm, the robot did not show red as one would expect when a cut is deep and mps noted that the surgeon did not appear to be skiving while cutting.Surgeon is requesting service.Mps also noted that the camera droops when it is moved to its leftmost or rightmost extremes.Case 1 of 3.

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.Device not returned.

Event Description

Mps reported inaccurate tka cuts + usb hub on gud not working + camera drooping.In the last 3 tka cases, all cuts made with the angled sawblade attachment (distal femur and posterior chamfer) were consistently deep by 1-2mm.Surgeon makes the angled sawblade cuts last.Mps confirmed that all pre-surgery checks passed along with the femur checkpoint and sawblade checkpoint prior to 'bone preparation'.Those tka cases varied between left and right operative sides, varus v valgus, etc.Despite being deep by 1-2mm, the robot did not show red as one would expect when a cut is deep and mps noted that the surgeon did not appear to be skiving while cutting.Surgeon is requesting service.Mps also noted that the camera droops when it is moved to its leftmost or rightmost extremes.Case 1 of 3.

Event Description

Mps reported inaccurate tka cuts + usb hub on gud not working + camera drooping.In the last 3 tka cases, all cuts made with the angled sawblade attachment (distal femur and posterior chamfer) were consistently deep by 1-2mm.Surgeon makes the angled sawblade cuts last.Mps confirmed that all pre-surgery checks passed along with the femur checkpoint and sawblade checkpoint prior to 'bone preparation'.Those tka cases varied between left and right operative sides, varus v valgus, etc.Despite being deep by 1-2mm, the robot did not show red as one would expect when a cut is deep and mps noted that the surgeon did not appear to be skiving while cutting.Surgeon is requesting service.Mps also noted that the camera droops when it is moved to its leftmost or rightmost extremes.Case 1 of 3.

Manufacturer Narrative

Reported event.An event regarding inaccurate resection involving a mako robotic arm was reported.The event was confirmed.Method & results.-product evaluation and results: the field service engineer reported: problem reproduced? yes.Trouble shooting notes: none.Work performed: (b)(4) - mps (b)(6) reported inaccurate tka cuts usb hub on gud not working camera drooping.During investigation, found that j2 bump stops were not in spec, allowing for more travel in the joint and affecting cuts.Set up j2 bump stops to spec 10° right, 32° left, performed find homing constants and performed kinetic calibration on both sides of the system.Re-torqued the camera handle to prevent drooping.Checked the usb hub on the gud, found the usb connection in the back of the gud computer was loose not allowing a permanent connection.Now the usb hub connects with no issues.Work order disposition: system investigation completed successfully as per service manual.All system checks and tests passed, system is ready for use.-clinician review: no medical records were received for review with a clinical consultant.-product history review: a review of device history records shows that (b)(6) was inspected and the quality inspection procedures were completed with no reported discrepancies.-complaint history review: a review of complaints in trackwise related to p/n 219999, robot number: (b)(4) shows 0 additional complaints related to the failure in this investigation.Conclusions: the alleged failure mode was confirmed, as per the field service engineer visit, to be potentially caused by the j2 bump stops not being in spec, allowing for more travel in the joint and affecting cuts.Based on the information reviewed there is no indication of any inherent software issue.No additional investigation or specific actions are required.If additional information is received, then the complaint will be reopened.

• Brand Name: MAKO ROBOTIC ARM 3.1
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer (Section G): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer Contact: perla zima ; 2555 davie road; centennial park, elstree; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 13588249
• MDR Text Key: 286173457
• Report Number: 3005985723-2022-00018
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 07613327395280
• UDI-Public: 07613327395280
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193515
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/18/2022

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: 219999
• Device Catalogue Number: 219999
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/28/2022
• Initial Date FDA Received: 02/23/2022
• Supplement Dates Manufacturer Received: 04/29/2022
• Supplement Dates FDA Received: 05/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other