MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA NEURAWRAP NERVE PROTECTOR 10MM ID X 4CM LENGTH

Catalog Number	NW1040
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Event or Problem Description
A nurse reported a neurawrap (id: (b)(4) was implanted on (b)(6) 2024.Approximately 26 days after implantation of neurawrap nerve protector, patient developed symptoms of worsening swelling with neuropathic and cutaneous pain.Initial treatment was medrol dosepak with symptoms returning after treatment completed.Secondary treatment involved gabapentin 100mg tid, compression, rom exercises.Nine weeks from initial surgery date, the symptoms continued to worsen, therefore the neurawrap was removed on (b)(6) 2024.Cultures and specimen were sent to laboratory and showed a "fibrino-inflammatory exudate" with cultures showing "no growth" at 5 days.After the product was removed, patient had dramatic improvement of symptoms.Reason for neurawrap use: right recurrent carpal tunnel syndrome with cutaneous neuroma.The decision was made to perform a nerve wrap to prevent further scar adhesions to the median nerve at the site of maximal insult.
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.
Additional Manufacturer Narrative
The neurawrap (id nw1040) was not returned for evaluation however, samples from the same lot/batch retained by manufacturer were evaluated.Dhr - lot 7070587 was reviewed and no anomaly was observed during its manufacturing, packaging, and inspection processes that could be related to the reported condition.Failure analysis - retain samples: three (3) neurawrap units were visually inspected.Dispenser boxes and trays were in good condition.The sealing area was complete and in good condition.No defect was observed on the product.Root cause analysis - there is insufficient information to conclude whether or not the adverse event was due to the neurawrap, patient hypersensitivity to the neurawrap or if the event may have been surgical technique related.¿ therefore, based on the available information, it is not possible to confirm that the neurawrap product used is causal to the reported condition.A medical assessment was requested to integra's safety team and the following was provided: "neurawrap nerve protector is indicated for the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue.Neurawrap nerve protector is contraindicated for patients with a known history, of hypersensitivity to bovine derived materials.Neurawrap is generated from integra¿s ultra pure collagen technology.As per the complaint reported, neurawrap was used on the patient to prevent further scar adhesions to the median nerve at the site of maximal insult for recurrent carpal tunnel syndrome with cutaneous neuroma.The patient developed symptoms of worsening swelling with neuropathic and cutaneous pain approximately 26 days after implantation.Possible complications can occur with any peripheral nerve surgical procedure including pain, infection, decreased or increased nerve sensitivity, and complications associated with use of anesthesia.In addition, details surrounding the intra-operative procedure and surgical technique used by the surgeon were not provided.The device must be flexible and soft so as to prevent compression and limit tissue inflammation." "at this time, there is insufficient information to conclude whether or not the adverse event was due to the neurawrap, patient hypersensitivity to the neurawrap or if the event may have been surgical technique related." additional information received: medwatch form information received on 21nov2024: mdr report #: mw5160570.Patient weight (kg): 61.Initial reporter asked to remain confidential? y.

• Brand Name: NEURAWRAP NERVE PROTECTOR 10MM ID X 4CM LENGTH
• Common Device Name: NEURAWRAP
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 20472832
• Report Number: 2648988-2024-00038
• Device Sequence Number: 12665741
• Product Code: JXI
• UDI-Device Identifier: 10381780026402
• UDI-Public: 10381780026402
• Combination Product (Y/N): N
• PMA/510(K) Number: K041620
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2025
• Device Catalogue Number: NW1040
• Device Lot Number: 7070587
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2024
• Supplement Date Received by Manufacturer: 11/25/2024
• Initial Report FDA Received Date: 10/17/2024
• Supplement Report FDA Received Date: 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/03/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White