MAUDE Adverse Event Report: MAKO SURGICAL CORP. CHECKPOINT 3.5MM HEX X 15MM STERILE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	116230
Medical Device Problem Codes	Material Fragmentation (1261); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As part of normal complaint follow-up, an evaluation of the event has been initiated by mako surgical.A supplemental report will be submitted if additional information becomes available.
Event or Problem Description
This event occurred before removing the mako check point pin on mako tha procedure.Dr.Tells sale rep that the checkpoint pin on the molar was not found and may have entered the molar.Dr.Decided that it would be more beneficial to the patient to leave the checkpoint pin in place rather than perform a cup replacement to remove the checkpoint pin.An x-ray of the frontal view was then taken to confirm that the internal disc had not been penetrated, and the remaining checkpoint pin and mako pin were removed to close the wound.After procedure, dr.And sales rep have checked the postoperative ct.The pin had sunk to around 20mm below where it was originally struck.It was determined that it did not penetrate the inner bedrock.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Reported event: an event regarding other (checkpoint left in patient) involving a mako checkpoint driver was reported.The event was confirmed.Method & results: -product evaluation and results: the alleged failure is confirmed as reported by the complainant.Product cannot be returned as it is left in the patient as reported by the complainant.-clinician review: no medical records were received for review with a clinical consultant.-product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there are no other complaints with a similar failure mode for this lot.-user guide: a review of the mako tha 4.1 application user guide found the following information relevant to the reported event: remove checkpoints this page is intended to be used as a ¿patient time out¿ to ensure removal of all checkpoints from the patient before shutting down the system.The pelvic and femoral checkpoints can be removed using the ratcheting screw driver handle with the 3.5 mm hex head straight screwdriver.It is recommended that screw holding forceps are used to assist in checkpoint removal.When the surgeon has confirmed removal of both the pelvic and femoral checkpoints from the patient, the mps can select ¿done¿.Conclusions: the alleged failure mode was confirmed because the product was not available for inspection.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.

• Brand Name: CHECKPOINT 3.5MM HEX X 15MM 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: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 22199392
• Report Number: 3005985723-2025-00260
• Device Sequence Number: 18070974
• Product Code: OLO
• UDI-Device Identifier: 00848486002978
• UDI-Public: 00848486002978
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K112507
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2025

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: 116230
• Device Lot Number: 29023700-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/22/2025
• Supplement Date Received by Manufacturer: 09/27/2025
• Initial Report FDA Received Date: 06/12/2025
• Supplement Report FDA Received Date: 10/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/27/2025
• 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 Age: 49 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian