MAUDE Adverse Event Report: MAKO SURGICAL CORP. MAKO ROBOTIC ARM 3.1; STEREOTAXIC DEVICE, ROBOTICS

Model Number 219999

Device Problems Unintended System Motion (1430); Failure to Calibrate (2440)

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

Event Date 07/06/2022

Event Type  malfunction  

Event Description

Mps reported arm dropping out of haptics and inaccurate cuts.When surgeon presses mics trigger for motorized alignment, arm moves into haptics as expected as system shows green.As soon as surgeon releases the trigger, the arm drops a few inches, exits haptics, and the system shows red.Surgeon has also noted inaccurate cuts and is requesting a service visit.I confirmed with mps and arm orientation and patient positioning were are correct.We also confirmed that sawblade and bone checkpoints passed just prior to entering haptics.Case completed robotically.

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.

Event Description

Mps reported arm dropping out of haptics and inaccurate cuts.When surgeon presses mics trigger for motorized alignment, arm moves into haptics as expected as system shows green.As soon as surgeon releases the trigger, the arm drops a few inches, exits haptics, and the system shows red.Surgeon has also noted inaccurate cuts and is requesting a service visit.I confirmed with mps and arm orientation and patient positioning were are correct.We also confirmed that sawblade and bone checkpoints passed just prior to entering haptics.Case completed robotically.

Manufacturer Narrative

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? no.Trouble shooting notes: could not duplicate issue.Work performed: adjusted j2 bump stop.Performed kin-cal on right side to optimize values.Performed find gravity constance for anscpach, hip and mics.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 rob490 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)(6) shows other complaints related to the failure in this investigation.Conclusions: the alleged failure mode was not reproduced through an onsite inspection carried out by a field service engineer however the failure was confirmed to have been caused by bump stops being out of alignment.The system was optimized for clinical use.Additionally, a complaint history review provides no indication of any inherent software/ hardware 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: STEREOTAXIC DEVICE, ROBOTICS
• 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: juana hiciano ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15109701
• MDR Text Key: 300730120
• Report Number: 3005985723-2022-00100
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 07613327395280
• UDI-Public: 07613327395280
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/20/2022

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 Model Number: 219999
• Device Catalogue Number: 219999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/06/2022
• Initial Date FDA Received: 07/27/2022
• Supplement Dates Manufacturer Received: 09/22/2022
• Supplement Dates FDA Received: 10/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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