MAUDE Adverse Event Report: ATRIUM MEDICAL CORP C-QUR TACSHIELD; MESH, SURGICAL, POLYMERIC

Model Number	31633
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/08/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be submitted after the completion of the investigation into this event.
Event or Problem Description
During an open ventral hernia case there were two pieces of mesh in the sterile packet of a tacshield rather than one.
Additional Manufacturer Narrative
Engineering analysis: engineering reviewed the sterilization and device history records for the product in question and review showed that criteria was met.Engineering summary: the picture provided by the hospital shows a "spare" piece of tacshield after implanting one of the devices.The spare part was discarded rather than sent back for evaluation, so engineering cannot confirm the tacshield in the picture was the one scrapped in process.A review of past product complaints by the complaints department show that we have not had a complaint for multiple parts in the same packaging.Given the controls in place, this is likely an isolated incident that was not identified during the 100% inspection visual inspection just prior to placing product in a handling sleeve in process.As far as the assessment of whether or not the parts were sterile, engineering is confident that the two pieces of c-qur tacshield cited in the complaint were not a worst case challenge when compared to the validations that had been performed.Based on the assessment detailed in the investigation and the results from those sterilization validations, the parts are sterile and should perform as intended.Clinical evaluation: if there is a compromise in the integrity of the packaging of a sterile device, it would be noticed prior to being introduced to the surgical site.This may create a delay in the procedure while a second device is located and prepped.The complaint states that two pieces of mesh were found inside the sterile packet instead of just one.In the event that an additional piece of the product was added to the package after receipt at the facility the sealed pouch and the seal on the outer box would be broken.The instructions for use warn, 'this device is supplied sterile.Please inspect packaging to ensure it is intact and not damaged prior to use.'.

• Brand Name: C-QUR TACSHIELD
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL CORP; 40 continental blvd.; merrimack NH 03054
• MDR Report Key: 6095395
• Report Number: 3011175548-2016-00009
• Device Sequence Number: 13793102
• Product Code: FTL
• UDI-Device Identifier: 00650862316339
• UDI-Public: 00650862316339
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K100076
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2016

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
• Operator of Device: Physician
• Device Expiration Date: 08/11/2019
• Device Model Number: 31633
• Device Catalogue Number: 31633
• Device Lot Number: 408265
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/08/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/11/2016
• Supplement Report FDA Received Date: 12/28/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1