MAUDE Adverse Event Report: VILEX, LLC TITANEX; TTIANEX DRIVER T6 CANNULATED

Model Number	ZT702-06-09
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During an mis hammertoe procedure, the joint was prepped and pre-drilling performed prior to screw insertion.While advancing the screw, a small snap was heard causing the screwdriver to lose engagement.Driver tip was inspected and noticeably broken.A second driver was used and resulted in the same breakage.Larger incision was made in order to remove the driver fragments, total delay in surgery est.45 minutes.

• Brand Name: TITANEX
• Common Device Name: TTIANEX DRIVER T6 CANNULATED
• Manufacturer (Section D): VILEX, LLC; 111 moffitt street; mcminnville TN 37110
• Manufacturer Contact: emily womack ; 111 moffitt street; mcminnville, TN 37110 ; 8005215002
• MDR Report Key: 24506207
• Report Number: 1051526-2026-00002
• Device Sequence Number: 18631932
• Product Code: HXX
• UDI-Device Identifier: 00841731116253
• UDI-Public: 00841731116253
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 03/04/2026

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: ZT702-06-09
• Device Catalogue Number: ZT702-06-09
• Device Lot Number: 208277
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2025
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown