MAUDE Adverse Event Report: MAKO SURGICAL CORP. BONE PIN 3.2MM X 140MM STERILE 2 PACK; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	213527
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	08/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Mako tka for right knee was performed on (b)(6) 2024.The revision surgery was performed on (b)(6) 2024 because the fracture of the femoral shaft occurred at the femoral pin insertion site.The causal relationship and when the fracture occurred are unknown.
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.

• Brand Name: BONE PIN 3.2MM X 140MM STERILE 2 PACK
• 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: alessandra chavez ; 3365 enterprise ave; weston, FL 33331 ; 9546280700
• MDR Report Key: 20272716
• Report Number: 3005985723-2024-00163
• Device Sequence Number: 17935853
• Product Code: OLO
• UDI-Device Identifier: 07613327412376
• UDI-Public: 07613327412376
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K191998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/20/2024

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
• Device Catalogue Number: 213527
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/29/2024
• Initial Report FDA Received Date: 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian