MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA NEURAWRAP NERVE PROTECTOR 10MM ID X 2CM LENGTH

Model Number	NW1020
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Skin Inflammation/ Irritation (4545)
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported inflammation and suspected hypersensitivity to neurawrap.Patient had neurawrap nerve protector inserted on (b)(6) 2019.
Additional Manufacturer Narrative
The allegation in the complaint could not verified because the product sample was not available for further evaluation.In addition, the device history record of the reported finished good lot was review and no anomaly was observed during its manufacturing, packaging, and inspections process that could be related to the reported condition.The product ifu states that the use of this product is contraindicated for patients with a known history of hypersensitivity to bovine derived materials.At this time, there is no information about the patient¿s allergy/sensitivity history.No retain samples are available for evaluation since the reported fg lot expired on 12/31/20 and as per sop, collagen and biopatch protective disk retain program, the samples are retained for one (1) year beyond the expiration date of the fg product lot.In addition, integra's scientific affairs department was consulted on the reported event, the following was stated: ¿from the scant information available, i see that this case was a repair of the median nerve in the lower forearm of the right hand.18 months after the original repair, the operative site was widely re-explored.The images show tissue adherent to the nerve over its course through, what was, the carpal tunnel.There is a large neuroma at the proximal end of the nerve in the surgical exposure.From what i see in the images, plus the length of time to the re-exploration, it looks like the median nerve repair procedure was not successful and resulted in the large neuroma due to failed regeneration.In the images there are some suture presents on the ulnar side of the neuroma and at the distal end of the carpal tunnel, the sutures look like 7/0 material that is much larger than the 9/0 0r 10/0 material that is normally used in nerve repair procedures.This is neurawrap, however, except for the longitudinal slot, it is identical to neuragen.Neuragen clinical trial was done on median or ulnar nerves at this location in the forearm.Inflammation was not observed in any patient in the trial and functional recovery was excellent.¿ based on the scientific affairs assessment provided the possible root cause for the reported condition is most likely related to an unsuccessful nerve repair procedure that resulted in the large neuroma due to failed regeneration and not to product use.
Additional Manufacturer Narrative
This report is to add "medical device problem code 1" not included in the initial report: a24.

• Brand Name: NEURAWRAP NERVE PROTECTOR 10MM ID X 2CM LENGTH
• Common Device Name: NEURAWRAP
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 16257710
• Report Number: 2648988-2023-00002
• Device Sequence Number: 5273046
• Product Code: JXI
• UDI-Device Identifier: 10381780071808
• UDI-Public: 10381780071808
• Combination Product (Y/N): N
• PMA/510(K) Number: K041620
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: NW1020
• Device Catalogue Number: NW1020
• Device Lot Number: 3364484
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/04/2023
• Supplement Date Received by Manufacturer: 05/09/2024
• Initial Report FDA Received Date: 01/27/2023
• Supplement Report FDA Received Date: 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Unknown