MAUDE Adverse Event Report: VILEX, LLC ALPHALOK; T10 SELF RETAINING DRIVER

Model Number	TXD-T10
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vilex was initially made aware of the issue of the driver tip breaking on (b)(6) 2023.On (b)(6) 2023 it was determined that the complaint was reportable based on the additional information provided by the sales rep on (b)(6) 2023.The driver is used to insert screws into bone plates.The surgical technique for this system includes guidelines for pre-drilling prior to driving the screws to help reduce insertion torque into hard coritical bone.If the pre-drill is not used or the plate screw is inserted past the pre-drill, the driver may receive excessive torque which can cause the failure of the driver tips.Review of the dhr shows no deviations.Two complaints were opened previously due to similar issues.No other quality records were issued.
Event or Problem Description
Issue involving an implant driver instrument.While inserting a bone screw, the tip of the driver twisted off.The tip was unable to be retrieved and was left in the patient.

• Brand Name: ALPHALOK
• Common Device Name: T10 SELF RETAINING DRIVER
• Manufacturer (Section D): VILEX, LLC; 111 moffitt street; mcminnville TN 37110
• Manufacturer (Section G): VILEX, LLC; 111 moffitt street; mcminnville TN 37110
• Manufacturer Contact: emily womack ; 111 moffitt street; mcminnville, TN 37110 ; 9314747552
• MDR Report Key: 18172508
• Report Number: 1051526-2023-00002
• Device Sequence Number: 7716746
• Product Code: HXX
• UDI-Device Identifier: 00841731129703
• UDI-Public: 00841731129703
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K221558
• 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: Replace
• Type of Report: Initial
• Report Date (Section B): 11/15/2023

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: TXD-T10
• Device Catalogue Number: TXD-T10
• Device Lot Number: 13184
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2022
• 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
• Patient Sex: Unknown