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

Catalog Number	116230
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Pelvic pin broken off.
Additional Manufacturer Narrative
An event regarding crack/fracture involving a mako checkpoint was reported.The event was confirmed.Method & results: -product evaluation and results: functional inspection confirmed the event.Device has a crack along the base.-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 have been 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.

• 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, NJ NA ; EI NA ; 2018315000
• MDR Report Key: 22663299
• Report Number: 3005985723-2025-00351
• Device Sequence Number: 3678206
• Product Code: OLO
• UDI-Device Identifier: 00848486002978
• UDI-Public: 00848486002978
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K170593
• 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): 12/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 116230
• Device Lot Number: 29038900-0.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/09/2025
• Supplement Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2023
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male