MAUDE Adverse Event Report: VILEX, INC. VILEX HEMI IMPLANT

Model Number CHI-2CH

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/11/2016

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2016, vilex received call from an account manager that during surgery the wire ceased on a 1st mpj hemi implant.On (b)(6) 2016, vilex received the implant.On (b)(6) 2016, vilex's quality department inspected the implant and found no issues.Qc department used a test wire and it passed freely thru the implant.Vilex suspects that the doctor bent the wire thus causing the implant to cease.If a wire has the slightest bend, the implant will not move.The facility had disposed of the wire.Without the actual wire that was used in surgery, vilex is unable to confirm complaint.If further information becomes available, a supplement report will be filed.

Event Description

Wire ceased in cannulated hemi implant.

• Brand Name: VILEX HEMI IMPLANT
• Type of Device: HEMI
• Manufacturer (Section D): VILEX, INC.; 111 moffitt street; mcminnville TN 37110
• Manufacturer (Section G): VILEX, INC.; 111 moffitt street; mcminnville TN 37110
• Manufacturer Contact: sylvia southard ; 111 moffitt street; mcminnville, TN 37110 ; 8005215002
• MDR Report Key: 5686469
• MDR Text Key: 47258738
• Report Number: 1051526-2016-00006
• Device Sequence Number: 1
• Product Code: KWD
• Combination Product (y/n): N
• PMA/PMN Number: K102401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/27/2016

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
• Device Operator: Health Professional
• Device Model Number: CHI-2CH
• Device Lot Number: 5269
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/11/2016
• Initial Date FDA Received: 05/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2012
• 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