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 03/09/2021

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.

Event Description

Could not get femur to pass registration.Lateral side was deep and medial side was proud.Actions: verified correct patient and side.Cleared all landmarks and retook (several times) reset landmarks checked segmentation check visidisc changed probe changed array hard shut down and restart reset arm software checked camera for cleanliness tourniquet time was extended due to issues and case was completed with navigation.Surgical delay: > 30 minutes.Surgery was completed manually.Case type / application: tka.

Manufacturer Narrative

An event regarding registration fails involving a mako tka software was reported.The event was not confirmed because the product was not available for inspection.Method & results -product evaluation and results: product inspection could not be performed as the product was not made available for evaluation within 60 days of the complaint being opened.The complaint will be closed with an associated risk assessment.Additional failures will be assessed once the product becomes available.-clinician review: no medical records were received for review with a clinical consultant.-product history review: a review of device history records shows that rob1090 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: rob1090 shows 0 similar complaints for tka software - registration fails.Conclusions: the exact cause of the event could not be determined because insufficient information was made available for evaluation.Review of the log/session files has not been completed within 60days of the complaint being opened.A review of the case session/log data is needed to complete a full investigation for determining root cause.In addition to a review of the log/session, a field service engineer conducts scheduled maintenance on the robot to ensure the robot is system ready.Once the review of the log/session files has been completed then the complaints team will reopen and re-evaluate the complaint.Product surveillance will continue to monitor for trends.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.

Event Description

Could not get femur to pass registration.Lateral side was deep and medial side was proud.Actions: verified correct patient and side cleared all landmarks and retook (several times) reset landmarks checked segmentation check visidisc changed probe changed array hard shut down and restart reset arm software checked camera for cleanliness tourniquet time was extended due to issues and case was completed with navigation.Surgical delay: > 30 minutes.Surgery was completed manually.Case type / application: tka.

• 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
• MDR Report Key: 11618269
• MDR Text Key: 244212329
• Report Number: 3005985723-2021-00060
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 07613327395280
• UDI-Public: 07613327395280
• 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: 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2021
• 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?: No
• Date Manufacturer Received: 06/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 34 YR