MAUDE Adverse Event Report: MAKO SURGICAL CORP. TIBIAL CHECKPOINT STERILE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	111651
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Checkpoints were not added to back table count.Plan was archived and exited without confirming checkpoints were removed.Therefore, checkpoints (one femoral, one tibial) were left in patient.The surgeon is not planning on removing checkpoints.If they begin to bother the patient following post op appointments, surgeon will decide to remove.Was a right total knee.Case type / application: tka 2.0.

• Brand Name: TIBIAL CHECKPOINT STERILE
• 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: 23486794
• Report Number: 3005985723-2025-00506
• Device Sequence Number: 13393536
• Product Code: OLO
• UDI-Device Identifier: 00848486001353
• UDI-Public: 00848486001353
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• 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
• Report Date (Section B): 11/06/2025

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: 111651
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2025
• Initial Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Sex: Female