MAUDE Adverse Event Report: VILEX IN TENNESSEE, INC. VILEX HEMI IMPLANT; CHI IMPLANT

Model Number CHI-2CH

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Information (3190)

Event Date 01/22/2018

Event Type  malfunction  

Manufacturer Narrative

Received call on (b)(6) 2018 from account manager that the wire could not be removed from an implant.Following surgical technique surgeon inserted the guidewire and used trial sizer to determine correct size of the implant need.Size was determined.Surgeon slid the implant over the guidewire and began advancing the implant.Before completely tighten the surgeon removed the driver and attempted to remove the guidewire.Surgeon tried removing the wire by holding down on the implant while pulling the wire.While doing so, he pulled the implant out of the canal.Once removed surgical tech tried to remove the wire from the implant and was unsuccessful.Implant-wire were cleaned and returned to vilex.January 24, 2018, vilex received the implant-wire from the account manager.January 31, 2018, vilex's quality department examined the implant-wire.The wire was found to be stuck at the insertion tip.Quality personnel was able to remove the wire from the implant.Wire size was checked and found to be 1.6mm.Implant cannulation was checked with a 1.6mm gage pin.No problem was found.Upon examining the wire, he found it to be bent.Wire also had nicks which could have possibly been from the wire driver used during surgery.It is believed the surgeon did not predrill the canal as he stated he inserted the wire and started driving the implant.As with any cannulated implant, the cannulation and the wire size depends on the wire being straight and the cannulation of the implant sliding freely over the wire.If the wire is bent during insertion, the implant cannot slide over the bend in the wire and will become galled to the implant.If more information becomes available a supplemental report will be filed.

Event Description

Received call on (b)(6) 2018 from account manager that surgeon had an issue removing the guidewire from the implant once it was partially implanted.

• Brand Name: VILEX HEMI IMPLANT
• Type of Device: CHI IMPLANT
• Manufacturer (Section D): VILEX IN TENNESSEE, INC.; 111 moffitt street; mcminnville 37110
• Manufacturer (Section G): VILEX IN TENNESSEE, INC.; 111 moffitt street; mcminnville TN 37110
• Manufacturer Contact: sylvia southard ; 111 moffitt street; mcminnville, TN 37110 ; 9314747550
• MDR Report Key: 7301590
• MDR Text Key: 101259239
• Report Number: 1051526-2018-00001
• Device Sequence Number: 1
• Product Code: KWD
• UDI-Device Identifier: 00841731106179
• UDI-Public: (01)00841731106179(10)5269
• Combination Product (y/n): N
• PMA/PMN Number: K102401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CHI-2CH
• Device Lot Number: 5269
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/22/2018
• Date Manufacturer Received: 01/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1