MAUDE Adverse Event Report: MAKO SURGICAL CORP. CAMERA, POLARIS VEGA ST; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 700000653914

Device Problems Electrical /Electronic Property Problem (1198); Unintended Movement (3026)

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

Event Date 12/29/2023

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 if additional information becomes available.

Event Description

Mps reported j5 is vibrating so much that rob is unable to remain within haptic boundaries to cut.Wo - replaced camera.Performed pre-surgery.Checked camera accuracy and optical compliance.Minor adjustment to j5 cable tension.Visually inspected all cables and wiring.Clapped brakes.No issues found other than camera bump sensor.System ready for clinical use.

Manufacturer Narrative

Update to the product grid as per service max.Upon additional information, the issue was discovered to be with a camera and is not related to a medical device, therefore this event is deemed no longer reportable.A review of the for total knee arthroplasty mako system a0017400 rev.Ai for potential adverse effects due to excessive vibration of system elements indicates that the highest potential severity of harm is s2 with a potential occurrence level o2.Additionally, a review of the complaint history data for the past 4 years indicated there have been no reports of serious injury or death as a result of similar events with this device family.Based upon this review, it is unlikely that a serious injury or death would result if this event were to recur.Therefore, this event is not reportable.An event regarding electronics failure involving a mako camera was reported.The event was confirmed.Method & results: -product evaluation and results:"the field service engineer reported: problem reproduced: no troubleshooting notes: none work performed: replaced camera.Performed pre-surgery.Checked camera accuracy and optical compliance.Minor adjustment to j5 cable tension.Visually inspected all cables and wiring.Clapped brakes.No issues found other than camera bump sensor.System 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: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there are no other complaints with a similar failure mode for this lot.Conclusions: the alleged failure mode was confirmed.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.

Event Description

Mps reported j5 is vibrating so much that rob is unable to remain within haptic boundaries to cut.Wo - replaced camera.Performed pre-surgery.Checked camera accuracy and optical compliance.Minor adjustment to j5 cable tension.Visually inspected all cables and wiring.Clapped brakes.No issues found other than camera bump sensor.System ready for clinical use.

• Brand Name: CAMERA, POLARIS VEGA ST
• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18524187
• MDR Text Key: 333214406
• Report Number: 3005985723-2024-00008
• Device Sequence Number: 1
• Product Code: OLO
• 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: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 700000653914
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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