MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION NEURAGEN NERVE GUIDE 2MM ID X 3CM LENGTH

Model Number	PNG230
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device involved in the reported incident is not available for evaluation.An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
A facility reported an expired neuragen nerve guide (id png230) was implanted.The expiration date is september 30, 2022 and was implanted on (b)(6) 2022.No patient injury reported, and no medical intervention required.Name of procedure: tenolysis excision.According to the information provided, it is unknown if the expiry date was checked before it was inserted, but it appears that it wasn¿t noticed that the product expired.The product remains implanted.
Additional Manufacturer Narrative
The neuragen nerve guide (id png230) was not returned for evaluation (remains implanted); however, investigation site retain samples were evaluated.Dhr - no product defect reported that would generate an investigation.Failure analysis - retain samples evaluation: six (6) units were visually inspected.Packaging was in good condition; tray seals were acceptable, and product/sponge appearance was normal.No defect was observed in any of the inspected units.The correct expiration date 09/30/2022 was observed in all labels.Expiration date is visible in four (4) different places: front and top side of the box, piggyback labels, and tyvek lid of product tray.The expiration date was as reported.The reported condition of ¿expired product implanted into patient¿ was confirmed with the dhr review and retain samples evaluation since the expiration date was on 30 september 2022 and implantation on 27 october 2022.The root cause for this complaint is the result of two (2) events caused by the customer: the expired stock was not disposed.It was not noticed that the product was expired prior to use.

• Brand Name: NEURAGEN NERVE GUIDE 2MM ID X 3CM LENGTH
• Common Device Name: NEURAGEN
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION; 105 morgan lane; 105 morgan lane; plainsboro NJ
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION; 105 morgan lane; plainsboro NJ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 16019344
• Report Number: 1121308-2022-00112
• Device Sequence Number: 12227180
• Product Code: JXI
• UDI-Device Identifier: 10381780026464
• UDI-Public: 10381780026464
• Combination Product (Y/N): N
• PMA/510(K) Number: K011168
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2023

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: 09/30/2022
• Device Model Number: PNG230
• Device Catalogue Number: PNG230
• Device Lot Number: 4951800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/01/2022
• Supplement Date Received by Manufacturer: 12/29/2022
• Initial Report FDA Received Date: 12/20/2022
• Supplement Report FDA Received Date: 01/06/2023
• Date Device Manufactured: 09/16/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Sex: Male