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

Catalog Number	209999
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2024
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 if additional information becomes available.
Event or Problem Description
This pi s for case 1 of 2 mps says that during tha reaming their inclination and version was off by a lot in a case last week which he thinks is a suboptimal (extra-articular surface points) however in the case today they went to ream and before actually powering the mics the system showed that the acetabulum was reamed to the point of being red.He said checkpoints passed and registration was accurate.Update 12/august/2024: mps reported inclination and version inaccuracy during tha, which mps attributes as possibly linked to poor registration pattern + red already showing up prior to reaming.Re-registration did not resolve.Checkpoints before and after cut attempts passed.This support case and work order are being submitted due to a spontaneous cancellation of a prior work order.
Event or Problem Description
This pi s for case 1 of 2.Mps says that during tha reaming their inclination and version was off by a lot in a case last week which he thinks is a suboptimal (extra-articular surface points) however in the case today they went to ream and before actually powering the mics the system showed that the acetabulum was reamed to the point of being red.He said checkpoints passed and registration was accurate.Update 12/august/2024: mps reported inclination and version inaccuracy during tha, which mps attributes as possibly linked to poor registration pattern + red already showing up prior to reaming.Re-registration did not resolve.Checkpoints before and after cut attempts passed.This support case and work order are being submitted due to a spontaneous cancellation of a prior work order.
Additional Manufacturer Narrative
Reported event.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: rob510 - mps reported inclination and version inaccuracy during tha, which mps attributes as possibly linked to poor registration pattern red already showing up prior to reaming.This support case and work order are being submitted due to a spontaneous cancellation of a prior work order.Work performed: thoroughly cleaned hybrid cables and connections, camera lenses, and monitors.Ensured proper tension of transmission cables as well as proper joint friction.Adjusted j2 bump stops to correct alignment.Upon failing auto arm accuracy checks, i performed kinematic calibration.Performed all proper tests and checks per service manual, including pre-surgery test on gud, system 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: 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 other complaints with a similar failure mode for this lot.Conclusions: the alleged failure mode was confirmed to be potentially caused by dislodged bump stops as per the field service engineer visit.Based on the information reviewed there is no indication of any inherent software issue.No additional investigation or specific actions are required.If additional information is received, then the complaint will be reopened.

• Brand Name: 3.0 RIO ROBOTIC ARM - 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: 20110969
• Report Number: 3005985723-2024-00139
• Device Sequence Number: 8474895
• Product Code: OLO
• UDI-Device Identifier: 00848486030407
• UDI-Public: 00848486030407
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2024

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
• Device Lot Number: ROB510
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/05/2024
• Supplement Date Received by Manufacturer: 10/28/2024
• Initial Report FDA Received Date: 08/30/2024
• Supplement Report FDA Received Date: 11/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2016
• 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 Sex: Unknown