MAUDE Adverse Event Report: TYRX, INC. AIGIS-R LARGE; MESH, SURGICAL, POLYMERIC

Model Number	NMRM6133
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/07/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation conclusion: lot# 16h15753 - the particle was located on the interior surface of the envelope.The particle had a dark and glassy appearance in the optical images.The particle was about 1mm in length.The sample was sent to the lab to determine the origin of the foreign matter.The unknown residue was thoroughly characterized by infrared spectroscopy and tof-sims.The results show the unknown material from the field return is similar to material from the spraying, and is composed of a mixture of thk afa grease and api coating (tyrosine polymer, minocycline and rifampin).A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during the implant procedure the absorbable envelope was opened and found to have a visible anomaly on the envelope, a black spec.The envelope was inspected before going to the sterile field by the implanting physician who determined it should be discarded.Another envelope was implanted.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
The device envelope was returned and analyzed.Analysis of the returned product indicated an issue with the device envelope appearance.There was a particle located on the interior surface of the envelope.The particle had a dark and glassy appearance in the optical images.The particle was about 1mm in length.The sample was sent to the lab to determine the origin of the foreign matter.The unknown residue was thoroughly characterized by infrared spectroscopy and time-of-flight secondary ion mass spectrometry (tof-sims).The results suggest the unknown material from the field return is similar to material from the spraying/drying oven, and is composed of a mixture of thk afa grease and active pharmaceutical ingredient (api) coating.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: AIGIS-R LARGE
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): TYRX, INC.; 1 deer park dr.; suites g, e; monmouth jct NJ 08852
• MDR Report Key: 6164742
• Report Number: 3005619263-2016-00055
• Device Sequence Number: 18919903
• Product Code: FTL
• UDI-Device Identifier: 00643169624795
• UDI-Public: 00643169624795
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K150291
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/07/2016

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: Health Professional
• Device Expiration Date: 09/30/2016
• Device Model Number: NMRM6133
• Device Catalogue Number: NMRM6133
• Device Lot Number: 16H15753
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2016
• Initial Date Received by Manufacturer: 09/07/2016
• Supplement Date Received by Manufacturer: Not provided; 10/10/2016
• Initial Report FDA Received Date: 12/09/2016
• Supplement Report FDA Received Date: 04/06/2017; 09/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 39 YR