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

Catalog Number	212186
Medical Device Problem Codes	Fracture (1260); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The following information was provided: straight attachment broke during bone preparation.Surgeon was cutting the posterior condyle when the attachment clearly became loose.Second mako knee tray opened and straight attachment replaced.
Event or Problem Description
Straight attachment broke during bone preparation; surgeon was cutting the posterior condyle when the attachment clearly became loose.Second mako knee tray opened and straight attachment replaced.Update, sawblade became loose in the attachment.
Additional Manufacturer Narrative
Upon further review of the information provided, this event has been determined to be non-reportable.Review of clinician approved risk documentation for this product family indicates that inadequate locking strength between devices is a known potential hazard, additionally a review of the complaint history data for the past 4 years indicated there have been no reports of serious injury or death as a result of similar events with this device family.It is unlikely that a serious injury or death would result if this event were to recur.The procedure was completed successfully, and no injury occurred.Based upon this review, this event is deemed not reportable.

• 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: 24095629
• Report Number: 3005985723-2026-00027
• Device Sequence Number: 10341249
• Product Code: OLO
• UDI-Device Identifier: 00848486032111
• UDI-Public: 00848486032111
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 04/10/2026

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: 35070325 / 3553608
• 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: 12/19/2025
• Supplement Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 01/16/2026
• Supplement Report FDA Received Date: 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2025
• 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 Sex: Unknown