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

Model Number 219999

Device Problems Positioning Failure (1158); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 03/14/2023

Event Type  malfunction  

Event Description

Mps reported inaccurate cuts.Trials are not fitting as expected.Sometimes medial side fits fine but lateral side is proud.So far, only noticed on right knees.All presurgery checks passed.No issues with rio registration, verification, bone registration, and checkpoints to enter bone prep.Issue is intermittent.As reported via complaint form: the surgeon stated the alignment of the robot is off which could have to do with cuts being skewed when the trials were placed.Case type / application: tka.

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.

Manufacturer Narrative

An event regarding inaccurate resection involving a mako robotic arm was reported.The event was not confirmed.Method & results.-product evaluation and results: the field service engineer reported: problem reproduced? no.Trouble shooting notes: none.Work performed: performed complete preventive maintenance under work order and found no issues or out of tolerance.Suggested to mps to look for outside factors that could cause discrepancy.System passes all functional tests and is ready for clinical use.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)(6) shows no 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 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.

Event Description

Mps reported inaccurate cuts.Trials are not fitting as expected.Sometimes medial side fits fine but lateral side is proud.So far, only noticed on right knees.All presurgery checks passed.No issues with rio registration, verification, bone registration, and checkpoints to enter bone prep.Issue is intermittent.As reported via complaint form: the surgeon stated the alignment of the robot is off which could have to do with cuts being skewed when the trials were placed.Case type / application: tka.

• Brand Name: MAKO ROBOTIC ARM 3.1
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 3365 enterprise ave; weston FL 33331
• Manufacturer (Section G): MAKO SURGICAL CORP.; 3365 enterprise ave; weston FL 33331
• Manufacturer Contact: susan kinney ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16657274
• MDR Text Key: 312551264
• Report Number: 3005985723-2023-00062
• 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: 04/21/2023

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
• Device Lot Number: ROB1898
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/14/2023
• Initial Date FDA Received: 03/31/2023
• Supplement Dates Manufacturer Received: 04/06/2023
• Supplement Dates FDA Received: 04/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2022
• 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