MAUDE Adverse Event Report: VILEX, LLC VILEX BONE PLATE SYSTEM; REAMER, METHEAD QC

Model Number P672-22-16

Device Problem Use of Device Problem (1670)

Patient Problem Insufficient Information (4580)

Event Date 05/11/2021

Event Type  malfunction  

Manufacturer Narrative

Vilex was notified on (b)(6) 2021 by the account manager that the doctor was unable to connect the stem of the reamer into his power unit.The reamer was received at vilex on (b)(6) 2021 for inspection.The reamer was inspected by vilex quality control.Upon inspection, there were visual markings on the stem of the reamer that indicated the reamer was not being used with the correct ao quick connect equipment.No other issues were found.The reamer functions as intended.Vilex discussed the use of improper equipment with the account manager.Account manager confirmed the equipment used was not the correct type of equipment to be used with this reamer.Vilex replaced the reamer with a different type that will work with the doctor's equipment.A review of vilex complaints, non-conformances, and capa's from 2017-present was conducted.No records were found for vilex methead reamer p672-22-16.

Event Description

Doctor was unable to connect the stem of the reamer to the power unit.

• Brand Name: VILEX BONE PLATE SYSTEM
• Type of Device: REAMER, METHEAD QC
• Manufacturer (Section D): VILEX, LLC; 111 moffitt street; mcminnville TN 37110
• MDR Report Key: 11987876
• MDR Text Key: 280458843
• Report Number: 1051526-2021-00004
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 00841731116567
• UDI-Public: 00841731116567
• Combination Product (y/n): N
• PMA/PMN Number: K041287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 06/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: P672-22-16
• Device Catalogue Number: P672-22-16
• Device Lot Number: 9775
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2021
• Date Manufacturer Received: 03/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1