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

Catalog Number NW1020

Device Problems Device Expiration Issue (1216); Shelf Life Exceeded (1567)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/04/2016

Event Type  Injury  

Event Description

It was reported a charge sheet was created/processed on (b)(6) 2016, used (1) piece of nw1020 with an expiration date of 31oct2015.The charge sheet indicates a surgery date of (b)(6) 2016.The product was confirmed to be used on a patient.It was reported the patient was not harmed and no efforts have been made to explant the implanted device.

Manufacturer Narrative

Integra completed its internal investigation 7jun2016.The investigation included: method: review of device history records.Review of complaint management database for similar complaints.Results: according to the dhr review, no anomalies were reported during the packaging process of this lot that could be related to the reported condition.Finished goods (fg) lot 1134428 was released on 11/15/13 and its expiration date is 2015-10.No similar complaints related to ¿use of expired product¿ have been reported for this fg lot 1134428.After reviewing the complaint system since 01/01/13 until 02/11/16, (b)(4) complaints (including the one being investigated) related to ¿use of expired product¿ have been reported.Approximately (b)(4) units of neurawrap products have been shipped for sales purposes since 2013 until 02/11/16, resulting in a complaint occurrence rate of approximately (b)(4).Conclusion: based on information provided on the complaint record and the failure analysis that was made taking into account the retain samples evaluation, the reported incident (use of expired product) could not be associated (confirmed) to the manufacturing / packaging process performed at integra (b)(4).Complaint unit was labeled in an accurate.The reported incident could be associated to the handling of the product (product misuse) at the reporting facility.

• Brand Name: NEURAWRAP NERVE PROTECTOR 10MM ID X 2CM LENGTH
• Type of Device: NEURAWRAP
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION; 105 morgan lane; 105 morgan lane; plainsboro NJ 08536
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION; 105 morgan lane; plainsboro NJ 08536
• Manufacturer Contact: maria leonard ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5461112
• MDR Text Key: 39079309
• Report Number: 1121308-2016-00005
• Device Sequence Number: 1
• Product Code: JXI
• Combination Product (y/n): N
• PMA/PMN Number: K011168
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2015
• Device Catalogue Number: NW1020
• Device Lot Number: 1134428
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other