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

Model Number FZ120-200T-25

Device Problem Failure to Osseointegrate (1863)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/27/2018

Event Type  malfunction  

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 Description

Fuze nail broke.

• Brand Name: FUZE INTRAMEDUALLARY NAIL
• Type of Device: FUZE
• Manufacturer (Section D): VILEX, INC.; 111 moffitt street; mcminnville 37110
• Manufacturer (Section G): VILEX, INC.; 111 moffitt street; mcminnville 37110
• Manufacturer Contact: sylvia southard ; 111 moffitt street; mcminnville, TN 37110 ; 9314747550
• MDR Report Key: 8201210
• MDR Text Key: 131714196
• Report Number: 1051526-2018-00007
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00841731107275
• UDI-Public: (01)00841731107275(10)7018
• Combination Product (y/n): N
• PMA/PMN Number: K102413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FZ120-200T-25
• Device Catalogue Number: FZ120-200T-25
• Device Lot Number: 7018
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1