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

Catalog Number	111645
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The following information was provided: clinical event information: they were doing a mako total hip replacement when the orthopaedic reg was removing the acetabulum checkpoint pin the head of the pin broke off from the pin.Leaving the tip of it retained in the patient.The surgeon and registrar tried to retrieve it, but it was buried in the bone.X-ray completed to confirm location.They were doing a mako total hip replacement when the orthopaedic reg was removing the acetabulum checkpoint pin the head of the pin broke off from the pin.Leaving the tip of it retained in the patient.The surgeon and registrar tried to retrieve it, but it was buried in the bone.X-ray completed to confirm location.Theatre coordinator informed.

• Brand Name: FEMORAL-TIBIAL CHECKPOINT KIT -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: 24040235
• Report Number: 3005985723-2026-00018
• Device Sequence Number: 13030430
• Product Code: OLO
• UDI-Device Identifier: 00848486029494
• UDI-Public: 00848486029494
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K220459
• 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): 05/14/2026

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: 111645
• Device Lot Number: 06242022-5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/17/2025
• Supplement Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2022
• 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