MAUDE Adverse Event Report: VILEX, LLC VILEX STAINLESS STEEL LAG SCREWS; LAG SCREWS, STAINLESS

Model Number	S30-18S-11
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vilex received a call from the account manager on 05/06/2021 regarding an issue he experienced with a guide wire not being able to pass through the cannulated screw.The screw was received at vilex on 05/07/2021 with a note stating that there was an issue with the threads of the screw.No wire was returned with the screw for inspection.Vilex reached out to the account manager multiple times to complete an issue review form to obtain more knowledge about the incident.The account manager has yet to return the completed form.The screw was inspected by vilex quality control.Quality control evaluated the screw.The screw was able to advance as intended.Cannulation was inspected and wires were able to pass through the screw without issue.No other issues could be found.Vilex also reviewed complaints, non-conformances, and capa's from 2017 to present.No records were found for vilex stainless steel lag screw s30-18s-11.Should more information become available, vilex will file a supplemental report.
Event or Problem Description
Account manager stated a guide wire could not pass through the cannulated screw.

• Brand Name: VILEX STAINLESS STEEL LAG SCREWS
• Common Device Name: LAG SCREWS, STAINLESS
• Manufacturer (Section D): VILEX, LLC; 111 moffitt street; mcminnville TN 37110
• MDR Report Key: 11942519
• Report Number: 1051526-2021-00003
• Device Sequence Number: 4359220
• Product Code: HWC
• UDI-Device Identifier: 00841731103420
• UDI-Public: 00841731103420
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K991551
• 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
• Type of Report: Initial
• Report Date (Section B): 06/04/2021

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: S30-18S-11
• Device Lot Number: 3170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/16/2007
• Initial Report FDA Received Date: 06/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1