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

Catalog Number	116230
Medical Device Problem Codes	Fracture (1260); Use of Device Problem (1670)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	03/06/2025
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
A checkpoint that was inserted outside of the acetabulum broke off and remained in the patient's bone.This was determined at the time of removal.
Additional Manufacturer Narrative
An event regarding other involving a mako checkpoint was reported.The event was confirmed.Method & results: -product evaluation and results: visual inspection confirmed the reported event.Checkpoint is broken.-clinician review: no medical records were received for review with a clinical consultant.-product history review: could not be performed as the lot details were not provided.-complaint history review: could not be performed as the lot details were not provided.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 3.5MM 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: 21732094
• Report Number: 3005985723-2025-00124
• Device Sequence Number: 14448379
• 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
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2025

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: UNKNOWN
• 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: 03/06/2025
• Supplement Date Received by Manufacturer: 06/20/2025
• Initial Report FDA Received Date: 03/31/2025
• Supplement Report FDA Received Date: 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Other
• Patient Sex: Female