MAUDE Adverse Event Report: MAKO SURGICAL CORP. 3.0 RIO® ROBOTICARM - 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	02/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Inaccuracy during pka case.The tibial implant isn't placed in the same position as the implant planning.All the verifications on the scan are correct.Additional information: yes a revision has been done during the case.Implant was cemented and removed to place a new implant from the same size.An engineer came during the weekend to fix the issue.
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
Inaccuracy during pka case.The tibial implant isn't placed in the same position as the implant planning.All the verifications on the scan are correct.Additional information: yes a revision has been done during the case.Implant was cemented and removed to place a new implant from the same size.An engineer came during the weekend to fix the issue.
Additional Manufacturer Narrative
Reported event: an event regarding incorrect placement involving a mako pka software was reported.The event was not confirmed.Method & results: -product evaluation and results: review of the case session files was not performed as case session data was not provided.In addition the mps did not provide the service case number.-clinician review: no medical records were received for review with a clinical consultant.-product history review: a review of device history records shows that rob was inspected and the quality inspection procedures were completed with no reported discrepancies -complaint history review: a review of complaints in trackwise shows no other similar complaints for pka software - incorrect placement.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: sanjana talathi ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18940305
• Report Number: 3005985723-2024-00032
• Device Sequence Number: 17849130
• Product Code: OLO
• UDI-Device Identifier: 00848486030407
• UDI-Public: 00848486030407
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2024

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: ROB435
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/23/2024
• Supplement Date Received by Manufacturer: 06/05/2024
• Initial Report FDA Received Date: 03/20/2024
• Supplement Report FDA Received Date: 06/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2016
• 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 Age: 71 YR
• Patient Sex: Female