MAUDE Adverse Event Report: MAKO SURGICAL CORP. MICS 3 ANGLED SAGITTAL SAW ATTACHMENT; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	210490
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An event regarding disassociation involving a mako saw attachment was reported.The event was confirmed.Method & results: product evaluation and results: functional inspection confirmed the event.Device is missing one of the screws.As per inspection by r&d: inspection it seems like the loctite on both of these screws is either missing or the correct quantity may not have been applied.If the items were washed after the issue, then it may be hard to draw any conclusions and we just have possibilities.This is true for the second complaint; i believe the first was cleaned somehow as it showed no evidence of having been removed from the patient.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate 8 devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other complaints with similar event(s) for the lot referenced.Conclusions: the alleged failure mode was confirmed.An nc has been opened to further investigate the problem.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.
Event or Problem Description
New angled saw attachment used for a mako tka.After using for intended use, we noticed that one of the screws was missing.Was able to locate it amongst the sterile drapes.Tka 2.0.

• Brand Name: MICS 3 ANGLED SAGITTAL SAW ATTACHMENT
• 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: alessandra chavez ; 3365 enterprise ave; weston, FL 33331 ; 9546280700
• MDR Report Key: 24108997
• Report Number: 3005985723-2026-00033
• Device Sequence Number: 20287630
• Product Code: OLO
• UDI-Device Identifier: 07613327523874
• UDI-Public: 07613327523874
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K241011
• 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
• Report Date (Section B): 01/19/2026

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: 210490
• Device Lot Number: ERPSJ3/0000000903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/30/2025
• Initial Report FDA Received Date: 01/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2025
• 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: 69 YR
• Patient Sex: Male