MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION NEURAGEN NERVE GUIDE 6MM ID X 3CM LENGTH

Catalog Number PNG630

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 Date 06/08/2016

Event Type  Injury  

Event Description

It is reported a device in consignment was used on (b)(6) 2016 but the device implanted had an expiry date of 30apr2016.No patient impact information provided.

Manufacturer Narrative

Integra has completed their internal investigation on 01/20/2017.The investigation activities included: methods: review of device history records.Review of complaint history.Results: the finished goods lot 1141379, catalog png630 ¿ (b)(4), was manufactured on 04/07/14 and its expiration date was 2016-04.The reported finished goods product lot associated with this complaint is neuragen nerve guide lot # 1141379 (anasco lot) for which the corresponding cmc plainsboro lot# is 105000300232.This product lot stems from the dispersion lot 105000300231.All testing met requirements, and were acceptable.Zero complaint of the same nature have been received for the past year (0 complaint / product uses).This is not statistically adverse when compared to the complaint rate for the prior time period (0 complaint / product uses).Conclusion: based on the investigation performed by integra, the complaint reported by the european hospital of marseille is not confirmed.As per the consignment contract signed between the customer and integra, this is the responsibility of the customer to manage expiry dates.Moreover, regardless of the contract, this is the responsibility of the hospital to check the implant (expiry date included) before implanting it into the patient.

• Brand Name: NEURAGEN NERVE GUIDE 6MM ID X 3CM LENGTH
• Type of Device: NEURAGEN
• 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: 5761264
• MDR Text Key: 48521408
• Report Number: 1121308-2016-00013
• 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: Audiologist
• Type of Report: Initial,Followup
• Report Date: 06/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2016
• Device Catalogue Number: PNG630
• Device Lot Number: 1141379
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2014
• 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