MAUDE Adverse Event Report: VILEX, INC. FUZE INTRAMEDUALLARY NAIL

Model Number	FZ120-200T-25
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vilex received call on (b)(6) 2018, regarding a broken 12mm fuze.(b)(6) 2015 - 12mm fuze (fz120-200t-25) was implanted in patient.(b)(6) 2018, surgery was performed to have the broken implant removed and a fusion revision was completed.Based on x-rays and discussion with the doctor, this was a non-union and the patient walked on it until it broke.A review of complaints was completed and none were found on any size of the 12mm fuze.A review of non-conformances was completed and none were found on this item, fz120-200t-25, lot 7018.If any additional information becomes available, vilex will file a supplemental report.
Event or Problem Description
Fuze nail broke.

• Brand Name: FUZE INTRAMEDUALLARY NAIL
• Common Device Name: FUZE
• Manufacturer (Section D): VILEX, INC.; 111 moffitt street; mcminnville 37110
• MDR Report Key: 8201210
• Report Number: 1051526-2018-00007
• Device Sequence Number: 10814819
• Product Code: HSB
• UDI-Device Identifier: 00841731107275
• UDI-Public: (01)00841731107275(10)7018
• Combination Product (Y/N): N
• PMA/510(K) Number: K102413
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/27/2018

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 Model Number: FZ120-200T-25
• Device Catalogue Number: FZ120-200T-25
• Device Lot Number: 7018
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/27/2018
• Initial Report FDA Received Date: 12/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1