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

Model Number TXD-T10

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/04/2023

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 328643608
• Report Number: 1051526-2023-00002
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 00841731129703
• UDI-Public: 00841731129703
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K221558
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1