MAUDE Adverse Event Report: MAKO SURGICAL CORP. CHECKPOINT 3.5 HEX IMPACTION STERILE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	111653
Medical Device Problem Codes	Fracture (1260); Material Fragmentation (1261)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582); Bone Notching (4890)
Date of Event	01/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The following information was provided: mako checkpoint impaction screw hex 3.5mm fracture.The fragment could not be removed and remains in the patient's body per the surgeon's judgment.
Additional Manufacturer Narrative
An event regarding crack/fracture involving a mako checkpoint was reported.The event was confirmed.Method & results: product evaluation and results: visual inspection confirmed the event.Checkpoint end angle is fracture (missing the tip).Confirmation of event: i can confirm that the patient had a cementless total hip arthroplasty since i was able to view x-rays with the implant in place.I can also confirm that there was a metallic foreign body.Retained in zone one above the cup, since i was able to see xrays with the foreign body.Root cause analysis: the root cause of this event cannot be determined with absolute certainty but in my opinion, this is an iatrogenic event.The impaction screw may have been positioned or inserted in an angulated or incorrect position which may have put on undo torque and stress, thereby causing fracture of the screw.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate the reported device was manufactured and accepted into final stock with no 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.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: 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: deepan raju srinivasan ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 24267816
• Report Number: 3005985723-2026-00051
• Device Sequence Number: 13429309
• Product Code: OLO
• UDI-Device Identifier: 00848486017316
• UDI-Public: 00848486017316
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K170593
• 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,Followup
• Report Date (Section B): 04/27/2026

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: 28926200-002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/09/2026
• Supplement Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2023
• 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