MAUDE Adverse Event Report: MAKO SURGICAL CORP. BONE PIN 4MM X 140MM STERILE 2PK; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	144140
Medical Device Problem Codes	Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	12/17/2024
Type of Reportable Event	Serious Injury
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 fracture occurred in the iliac crest of the healthy leg where the anchoring pin was placed.
Additional Manufacturer Narrative
This event is being reassessed as not reportable as there was no alleged malfunction of the device reported.There was no life-threatening injury resulting in permanent impairment/damage to a body part or structure, and the patient recovered with no medical/surgical intervention to preclude permanent impairment/damage to a body part or structure.A review of our physician approved risk tables, for excessive stress in bone, confirmed that the likelihood of any serious harm resulting from this incident is remote.Additionally, complaint history data for the past four years indicated there have been no reports of serious injury or death as a result of similar events with this device family.Therefore, this event is deemed not reportable.
Event or Problem Description
No new information.

• Brand Name: BONE PIN 4MM X 140MM STERILE 2PK
• 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: sanjana talathi ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21082755
• Report Number: 3005985723-2025-00010
• Device Sequence Number: 6765620
• Product Code: OLO
• UDI-Device Identifier: 00848486018177
• UDI-Public: 00848486018177
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K172219
• 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): 02/03/2026

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: 144140
• Device Lot Number: UNKNOWN
• 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: 12/17/2024
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 01/06/2025
• Supplement Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown