MAUDE Adverse Event Report: MAKO SURGICAL CORP. HIP END EFFECTOR VARIABLE ANGLE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	206967
Medical Device Problem Codes	Material Fragmentation (1261); Residue After Decontamination (2325)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2025
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
Dark gray particles were found inside the hip end effector after surgical procedure using mako robot.
Additional Manufacturer Narrative
Reported event.An event regarding foreign matter involving a mako end effector was reported.The event was not confirmed.Method & results.Product evaluation and results: visual inspection did not confirm the event.The device did not have dark gray particles inside.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 not confirmed.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.
Event or Problem Description
No new information.

• Brand Name: HIP END EFFECTOR VARIABLE ANGLE
• 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: 22313558
• Report Number: 3005985723-2025-00282
• Device Sequence Number: 18389551
• Product Code: OLO
• UDI-Device Identifier: 00848486022167
• UDI-Public: 00848486022167
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K170593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2025

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: 206967
• Device Lot Number: 1908190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/04/2025
• Supplement Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2023
• 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
• Patient Age: 30 YR
• Patient Sex: Female