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	09/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
This is for tka.Case number: (b)(4).(b)(6) reported that the robot has been inaccurate during surgery.For tka, alignment values never match the clinical values (e.G.System will show 0 degrees of varus/valgus alignment but clinical results show 11 degrees of valgus).
Additional 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 if additional information becomes available.
Event or Problem Description
This is for tka.Mps reported that the robot has been inaccurate during surgery.For tka, alignment values never match the clinical values (e.G.System will show 0 degrees of varus/valgus alignment but clinical results show 11 degrees of valgus).
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: rob081 - mps reported that the robot has been inaccurate during surgery.For tha it's been really hard to ream the green away and the cup will not seat fully.For tka, alignment values never match the clinical values e.G.System will show 0 degrees of varus/valgus alignment but clinical results show 11 degrees of valgus.Work performed: reported problem ¿ robot inaccurate during surgery.Observation ¿ j2 bump stop out of position.J5 & 6 cable tension loose.Arm accuracy warning on both sides.Action taken ¿ adjust j2 bump stop position.Adjust j5 & 6 cable tension.Kin-cal both sides.Re-install pka, tha, & tka.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.Successfully completed all checks, verifications, and calibrations.System is ready for clinical use.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: anna ryan ; raheen business park; limerick, FL NA ; EI NA ; 9546280700
• MDR Report Key: 20381880
• Report Number: 3005985723-2024-00183
• Device Sequence Number: 6566952
• Product Code: OLO
• UDI-Device Identifier: 00848486030407
• UDI-Public: 00848486030407
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 12/04/2024

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
• Device Catalogue Number: 209999
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/12/2024
• Supplement Date Received by Manufacturer: 11/11/2024
• Initial Report FDA Received Date: 10/07/2024
• Supplement Report FDA Received Date: 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2009
• 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