MAUDE Adverse Event Report: VILEX, INC. MINI MET HEAD

Model Number MMCI-13

Device Problem Break (1069)

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

Event Date 08/11/2016

Event Type  malfunction  

Manufacturer Narrative

On august 17, 2016, vilex received call that implant broke during surgery.Surgery was performed on patient's lesser toe.Account manager reported while the doctor was turning the implant the head of the implant snapped off the stem.The doctor was able to remove the stem portion of the implant from the patient and was able to implant another vilex mini met head without issue.Doctor reported that the patients bone was "like marble".Implants for lesser toes are very small and with the hardness of the bone, there is a possibility it could break at that point.Vilex was unable to evaluate the actual device as it was discard by the facility.The lot number is unknown, so no evaluation could be completed on an implant from the same lot.If more information could become available a follow up report will be completed.

Event Description

Implant broke.

• Brand Name: MINI MET HEAD
• Type of Device: MINI MET HEAD
• 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: 5922312
• MDR Text Key: 54437821
• Report Number: 1051526-2016-00007
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MMCI-13
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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