MAUDE Adverse Event Report: VILEX LLC VILEX LAG SCREW; STAINLESS STEEL LAG SCREW

Model Number	S30-16S-11
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6) 2020, vilex received call from an account manager that a doctor had issue with a (b)(4) not advancing.Account manager stated that the doctor inserted the guide wire into the surgical site.Doctor then proceeded to implant the screw by sliding it over the guide wire.As the doctor was attempting to insert the screw, the screw became stuck on the guide wire and would not advance.Vilex customer service asked the account manager to return the screw and the guide wire.On november 30, 2020 vilex received the screw and guide wire from the account manager.On (b)(6) 2020 vilex quality control department inspected the items return.Upon inspection, qc found that the guide wire was significantly bent and the screw tips were flared out.With the tips flared, this indicates the screw was trying to be inserted over a bent wire.This may have been caused by the guide wire being moved after being seated in the surgical site.Qc was able to remove the screw and upon further inspection of the guide wire, more bent areas were found where the screw had been stuck.Qc ran a guide wire through the screw and found no issues with the cannulation of the screw.(b)(4): instructions for use: bone screw system lists the proper procedure for inserting a guide wire.Copy of the document was sent to the account manager.Review of complaints, ncr and capas found no prior reporting for this item.This item is only marketed in the us.No further regulatory reporting is required.If more information becomes available vilex will submit an additional report.
Event or Problem Description
Doctor inserted kwire into surgical site and then attempted to slide stainless steel lag screw over the wire.Screw would not advance.

• Brand Name: VILEX LAG SCREW
• Common Device Name: STAINLESS STEEL LAG SCREW
• Manufacturer (Section D): VILEX LLC; 111 moffitt street; mcminnville TN 37110
• MDR Report Key: 11094936
• Report Number: 1051526-2020-00002
• Device Sequence Number: 13619808
• Product Code: HWC
• UDI-Device Identifier: 00841731103406
• UDI-Public: 00841731103406
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K991151
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/23/2020

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: S30-16S-11
• Device Catalogue Number: S30-16S-11
• Device Lot Number: 4052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1