MAUDE Adverse Event Report: VILEX, INC AVID MPT PLATE; AVID PLATE

Model Number	AMP45-5R
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Metatarsal-phalangeal joint arthrodesis was performed on the patient on (b)(6) 2018.The patient is an amputee that utilizes a prosthetic limb on the left foot.Follow up x-rays were done on (b)(6) 2018, (b)(6) 2018.The patient presented on (b)(6) 2018 for a routine follow up visit.The foot was x-rayed, and it showed the plate was broken.The patient is male and (b)(6).The patient was allowed to "early weight bear." the surgeon removed the hardware on (b)(6) 2018, performed a keller bunionectomy and specifically requested to keep all hardware.The sales representative was able to take a picture of the broken plate.Vilex has 0 prior complaints on the product# amp45-5r mpt plate (all lot numbers).Vilex has 0 prior complaints on all plates in the avid plate system.One ncr was found (17-018) for (26) asf104-9u fibula plates.The location of the k-wire hole was out of tolerance.This nonconformance has no effect on the issue with the broken plate.The device history record for this product lot was reviewed and there were no anomalies found.If any additional information becomes available a supplement report will be filed.
Event or Problem Description
Mpt plate broke.

• Brand Name: AVID MPT PLATE
• Common Device Name: AVID PLATE
• Manufacturer (Section D): VILEX, INC; 111 moffitt street; mcminnville TN 37110
• MDR Report Key: 7938504
• Report Number: 1051526-2018-00006
• Device Sequence Number: 16357820
• Product Code: HWC
• UDI-Device Identifier: 00841731108470
• UDI-Public: (01)00841731108470(10)9231
• Combination Product (Y/N): N
• PMA/510(K) Number: K041287
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: AMP45-5R
• Device Lot Number: 9231
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/11/2018
• Initial Report FDA Received Date: 10/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 0