MAUDE Adverse Event Report: COLLAGEN MATRIX, INC. NEUROMEND; COLLAGEN NERVE WRAP

Model Number	CNW4025
Medical Device Problem Code	Failure to Fold (1255)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the production records confirmed that the product met release criteria.Additional inspection and testing of the reserve samples was found to be conforming and met release criteria.Product testing did not re-produce the "horse shoe" shape non-conformance observed by the clinician.The product instructions for use indicate that "if there is no overlap and edges are approximated, the slit may be closed with a running suture".
Event or Problem Description
It was reported by the clinician that during the nerve repair procedure, the product would not wrap together as intended and would only form a "horse shoe" shape.The clinician decided to use another product and the procedure was successfully completed with a 15-20 minute surgical delay.No further information is available due to hospital policy.

• Brand Name: NEUROMEND
• Common Device Name: COLLAGEN NERVE WRAP
• Manufacturer (Section D): COLLAGEN MATRIX, INC.; 15 thornton road; oakland NJ 07436
• MDR Report Key: 8500782
• Report Number: 2249852-2019-00010
• Device Sequence Number: 1884699
• Product Code: JXI
• UDI-Device Identifier: 00813954020129
• UDI-Public: 00813954020129
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K060952
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/09/2019

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: 01/31/2021
• Device Model Number: CNW4025
• Device Lot Number: 1801182032
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/11/2019
• Initial Report FDA Received Date: 04/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other