MAUDE Adverse Event Report: MAKO SURGICAL CORP. 2.7 DEGREE STRAIGHT SAGITAL SAW; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	212186
Medical Device Problem Codes	Difficult to Insert (1316); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The following information was provided: after the procedure, this was discovered during instrument inspection.Since the procedure concluded without incident, no adverse events occurred.When securely attaching the saw blade to the mako mics sagittal saw straight attachment, lateral movement was observed.Additionally, the protruding section of the mics connection point also rotates.Continued use may cause the saw blade to loosen during mics operation, so replacement is requested.Update on 12/05/2025: 1.Could you please elaborate on what you mean by lateral movement? are you referring to a wider oscillation compared to the regular one? yes.During postoperative inspection, it was confirmed that the saw blade was securely fastened to the straight attachment, however lateral movement was observed by manual.

• Brand Name: 2.7 DEGREE STRAIGHT SAGITAL SAW
• 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: 23825985
• Report Number: 3005985723-2025-00613
• Device Sequence Number: 20091576
• Product Code: OLO
• UDI-Device Identifier: 00848486032111
• UDI-Public: 00848486032111
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K172219
• 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): 05/12/2026

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: 212186
• Device Lot Number: 35081124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/21/2025
• Supplement Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Unknown