MAUDE Adverse Event Report: VILEX, LLC VILEX DRIVER SHAFT; DRIVER, METHEAD SHAFT "1ST"

Model Number	X630-16-13
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter contacted vilex on december 8, 2022 to report the malfunction of the methead driver.One of the pins on the driver broke during the insertion of the implant.The pin remained in the implant with no protrusions and was unable to be removed.The incident happened towards the end of the surgery with the implant already fully seated.Surgeon decided to complete the surgery.No delay in surgery occurred.The reusable instrument was returned to vilex and examined by vilex quality control.Signs of damage were noticeable on the remaining pin of the instrument.No indication of misuse was found.All product dhrs were reviewed and no deviations were found relevant to the incident that occurred.No other quality records were found to be associated with the device.Due to the nature of the reusability of the device, probable root causes of the malfunction are excessive force during insertion or degradation after multiple uses over the course of 10+ years of field distribution.Should more information become available, vilex will file a supplemental report.
Event or Problem Description
Issue involving an implant inserter instrument.Towards the end of the surgery and the implant was fully seated, a pin from the inserter instrument broke in the implant.The piece was flush with the implant with no protrusions and the surgeon decided to complete the surgery.

• Brand Name: VILEX DRIVER SHAFT
• Common Device Name: DRIVER, METHEAD SHAFT "1ST"
• 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: 16159715
• Report Number: 1051526-2023-00001
• Device Sequence Number: 12278602
• Product Code: HWR
• UDI-Device Identifier: 00841731115942
• UDI-Public: 00841731115942
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K102401
• 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
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 01/13/2023

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: X630-16-13
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2010
• 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