MAUDE Adverse Event Report: MAKO Surgical Corp. CHECKPOINT 3.5 HEX IMPACTION STERILE; Orthopedic Stereotaxic Instrument

Catalog Number	111653
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The following information was provided: while removing the checkpoint from the patient's pelvis, the checkpoint fractured, leaving its tip inside the patient's body.The procedure was performed using a mako robot (rob 2408).

• Brand Name: CHECKPOINT 3.5 HEX IMPACTION 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 ; +1(201)831-5000
• MDR Report Key: 50728655
• Report Number: 3005985723-2026-00483
• Device Sequence Number: 21491060
• Product Code: OLO
• UDI-Device Identifier: 00848486017316
• UDI-Public: 00848486017316
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K093425
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/11/2026

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: 111653
• Device Lot Number: 29555200-006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 09/11/2026
• 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 Sex: Unknown