MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION NEURAWRAP NERVE PROTECTOR 3MM ID X 2CM LENGTH

Catalog Number NW320

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

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The device involved in the reported incident is not available for evaluation.An investigation has been initiated based on the reported information.

Event Description

It was reported that an expired product was implanted.No patient injury was reported.Request for additional information sent.

Manufacturer Narrative

Additional information received on (b)(6) 2016: it was reported that the doctor requested the use of nw320, and the nurse did not observe outdate before opening/use.This is the only lot involved.

Manufacturer Narrative

Integra has completed their internal investigation on june 9, 2016.The investigation included: methods: evaluation of actual device.Review of device history records.Review of complaints history.Results: evaluation of returned device; one (1) used package of neurawrap nerve protector 3mm id x 2cm length corresponding to fg lot # 1135110 was reported as the complaint unit.Since the unit was used it was not returned for evaluation.Ten (10) retain sample units were visually inspected for product and packaging appearance.No anomalies were observed.All units met product and packaging specifications.Dhr review; no anomalies were reported during the packaging process of this lot that could be related to the reported condition.Neurawrap nerve protector 3mm id x 2cm length, fg lot # 1135110 was manufactured through the following processes: cutting, inspection, trays cleaning, tyvek lids stamping and inspection, packaging, packaging inspection, bulk boxing, bulk boxing inspection, sterilization, piggyback and outer box labels printing, labels inspection, labels application and boxing, final inspection, and product release processes.Complaints history; approximately (b)(4) units of neurawrap products have been shipped for sales purposes since 2013 until 02/10/16, resulting in a complaint occurrence rate of approximately (b)(4).This was determined by dividing the number of complaints in this category (1) by the number of units shipped for sales purposes of the neurawrap units.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 to the manufacturing / packaging process performed at integra.Complaint unit was labeled in an accurate manner and applicable procedures.However, during the investigation it was confirmed that as reported by the customer, the integra sales department was responsible for the inventory.Therefore, the reported condition is confirmed taking into account the information received by the integra¿s regional sales manager.

• Brand Name: NEURAWRAP NERVE PROTECTOR 3MM 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: sonia irizarry ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5454990
• MDR Text Key: 39379783
• Report Number: 3003418325-2016-00004
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NW320
• Device Lot Number: 1135110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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