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

Catalog Number	209999
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2024
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 when additional information becomes available.
Event or Problem Description
Mps was in a tha care and while the surgeon was approaching for reaming he felt a jolt movement of the arm.Mps then went to test reamer and bone checkpoints and both of them passed.He said when the surgeon then went to rut the reamer back into the acetabulum the center of rotation was off by 5-8 mm posterior.He restarted arm software and then the system but they bailed manual.He performed pre-surg checks before the next case and all of them passed.In the next case everything was totally fine.Surgeon is requesting dispatch logs and file to be sent and a complaint is to be filed.They bailed to manual on the first case.
Event or Problem Description
Mps was in a tha care and while the surgeon was approaching for reaming he felt a jolt movement of the arm.Mps then went to test reamer and bone checkpoints and both of them passed.He said when the surgeon then went to rut the reamer back into the acetabulum the center of rotation was off by 5-8 mm posterior.He restarted arm software and then the system but they bailed manual.He performed pre-surg checks before the next case and all of them passed.In the next case everything was totally fine.Surgeon is requesting dispatch logs and file to be sent and a complaint is to be filed.They bailed to manual on the first case.
Additional Manufacturer Narrative
An event regarding unintended movement involving a mako robotic arm was reported.The event was confirmed.Method & results: -product evaluation and results: the field service engineer reported: problem reproduced: yes.Troubleshooting notes: none.Work performed: mps reported arm jolted.Observed camera drooping and dirty.Also observed dirty fibers.The camera has been tightened and cleaned.Kinematic calibration has been performed a s a preventative measure.All preventative maintenance procedures have been performed as well.Robot is ready for service.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 have been other complaints with similar event(s) for the lot referenced.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.

• 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: 18550388
• Report Number: 3005985723-2024-00010
• Device Sequence Number: 15350195
• Product Code: OLO
• UDI-Device Identifier: 00848486030407
• UDI-Public: 00848486030407
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 03/19/2024

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: ROB632
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/03/2024
• Supplement Date Received by Manufacturer: 02/21/2024
• Initial Report FDA Received Date: 01/22/2024
• Supplement Report FDA Received Date: 03/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2017
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown