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	12/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The following information was provided: screw came out of the angle saw attachment during the procedure in its first use ever.The screw almost landed in the wound of the patient.Case type / application: tka 2.
Additional Manufacturer Narrative
An event regarding disassociation involving a mako saw attachment was reported.The event was confirmed.Method & results: product evaluation and results: visual inspection confirmed the event.The screw is backing out of the device.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 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
No new information.

• 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: sanjana talathi ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23836560
• Report Number: 3005985723-2025-00622
• Device Sequence Number: 5093653
• Product Code: OLO
• UDI-Device Identifier: 07613327523874
• UDI-Public: 07613327523874
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2026

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: ERPTY0 / 0000001280
• 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: 12/05/2025
• Supplement Date Received by Manufacturer: 12/31/2025
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 01/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2025
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 4213847
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Male