MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORP NEURAGEN NERVE GUIDE 1.5MM ID X 3CM LENGTH

Model Number	PNG130
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Purulent Discharge (1812); Skin Infection (4544); Swelling/ Edema (4577)
Date of Event	10/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
This is 1 of 2 reports.Other mfg report no.: 1121308-2022-00020.A facility reported that a (b)(6) year old male patient with (png130) neuragen nerve guide had tissue post placement infection.It was noted that the patient had redness, swelling and purulent drainage of the hand.No culture was taken however, the infection was treated with oral antibiotics and wound care.Medical notes: "a (b)(6) year old male came to the clinic on (b)(6) 2021, requesting to be seen due to concerns for infection to his hand.He is 5 weeks out from zone 2 fds/fdp repair to right index, middle and ring finger.He has been working with therapy.He reports concerns for redness, swelling and purulent drainage.He occasionally notices a malodor.He was seen by the hand surgery pa and given 1 week prescription for clindamycin.Pain is actual and suspected with numeric pain score of 4.On the examination of right hand, skin surrounding surgical scar is pink/erythematous.There is open wound underlying the ring finger proximal phalanx approximately 2 x 2 cm which has a small area of necrotic tissue centrally.There is some slough surrounding this but no frank purulence.No malodor nor fluctuance.No tenderness however patient is numb distal to the zone of injury due to digital nerve lacerations.No tenderness tracking into palm.Patient gently range his digits without pain.He is stiff consistent with is postoperative status although flexor tendons do fire.Digits are pink warm and well-perfused." images: 3 views of right hand obtained with no evidence of fracture and no osteomyelitic changes.Patients medications: aspirin 81 mg oral capsule, 1 tab, po, daily.
Additional Manufacturer Narrative
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
N/a.
Additional Manufacturer Narrative
The neuragen nerve guide (png130) was not returned for evaluation however, retained samples were evaluated.Dhr review - record shows that results were found acceptable.The manufacturing process of fg lot 4842181 ran as expected and no assignable causes associated to the manufacturing process which could contribute and/or be related to the reported incident were identified.Failure analysis - visual inspection was performed to five retain samples of the reported finished good: dispenser was in good condition.No defect was observed on any the trays¿ appearance, sealing area, device¿s appearance, and no foreign material was observed inside the package.In addition, the last stability study for the neuragen product family was reviewed.It confirms that the product is compliant all through the product¿s shelf life including product sterility.Since the complaint could not be verified, the complaint is considered unconfirmed.Since the sample could not be returned for evaluation and based on the information provided by the customer, a root cause determination is not possible.

• Brand Name: NEURAGEN NERVE GUIDE 1.5MM ID X 3CM LENGTH
• Common Device Name: NEURAGEN
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORP; 1100 campus drive; 1100 campus drive; princeton NJ
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORP; 1100 campus drive; princeton NJ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 13952023
• Report Number: 1121308-2022-00019
• Device Sequence Number: 12390743
• Product Code: JXI
• UDI-Device Identifier: 10381780071822
• UDI-Public: 10381780071822
• Combination Product (Y/N): N
• PMA/510(K) Number: K011168
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: PNG130
• Device Catalogue Number: PNG130
• Device Lot Number: 4842181
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/04/2022
• Supplement Date Received by Manufacturer: 04/06/2022
• Initial Report FDA Received Date: 03/30/2022
• Supplement Report FDA Received Date: 04/19/2022
• Date Device Manufactured: 07/15/2020
• 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: 34 YR
• Patient Sex: Male