MAUDE Adverse Event Report: MAKO SURGICAL CORP. 3.0 RIO® ROBOTICARM - MICS; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	209999
Medical Device Problem Code	No Visual Prompts/Feedback (4021)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2023
Type of Reportable Event	Malfunction
Additional 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 when additional information becomes available.
Event or Problem Description
During a mako tha, when we brought the robot into ream the acetabulum the version numbers displayed on the monitor looked off and did not match what we were visually seeing.Checkpoints re verified and all were passing at approx 0.6mm.Re set arm software all fine, went back into case plan same incorrect numbers displayed, re registered robot and issue remained.At this stage we went to manual reaming and cup impaction.Surgical results obtained and same inclination number of 60 remained, despite having planned it at 40.Visually the impacted cup version looked the same as the planned cup visual on the 3d plan, confirmed with manual alignment handle that 40/20 version inclination was obtained.Final reduction result showed the cup position at the incorrect version not what was actually seen in the patient.Patient was under anaesthesia at the time with a delay of approx 15 mins.
Event or Problem Description
During a mako tha, when we brought the robot into ream the acetabulum the version numbers displayed on the monitor looked off and did not match what we were visually seeing.Checkpoints re verified and all were passing at approx 0.6mm.Re set arm software all fine, went back into case plan same incorrect numbers displayed, re registered robot and issue remained.At this stage we went to manual reaming and cup impaction.Surgical results obtained and same inclination number of 60 remained, despite having planned it at 40.Visually the impacted cup version looked the same as the planned cup visual on the 3d plan, confirmed with manual alignment handle that 40/20 version inclination was obtained.Final reduction result showed the cup position at the incorrect version not what was actually seen in the patient.Patient was under anaesthesia at the time with a delay of approx 15 mins.
Additional Manufacturer Narrative
Reported event an event regarding inaccurate values/visuals involving a mako tha software was reported.The event was not confirmed because the product was not available for inspection.Method & results product evaluation and results: the relevant log files and session files were not available for inspection.Clinician review: no medical records were received for review with a clinical consultant.Product history review: a review of device history records shows that rob276 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 209999, robot number: rob276 shows no other complaints related to the failure in this investigation.Conclusions: the alleged failure mode cannot be determined because the relevant log files and session files were not available for inspection.No additional investigation or specific actions are required.If additional information is received, then the complaint will be reopened.

• Brand Name: 3.0 RIO® ROBOTICARM - MICS
• Common Device Name: 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: 18316655
• Report Number: 3005985723-2023-00181
• Device Sequence Number: 6115503
• Product Code: OLO
• UDI-Device Identifier: 00848486030407
• UDI-Public: 00848486030407
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K170593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 209999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/27/2023
• Supplement Date Received by Manufacturer: 03/05/2024
• Initial Report FDA Received Date: 12/13/2023
• Supplement Report FDA Received Date: 04/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/22/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 44 YR
• Patient Sex: Female
• Patient Weight: 115 KG