MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION TENOGLIDE TENDON PROTECTOR SHEET SINGLE 2IN X 2IN 5CM

Catalog Number TG221

Device Problem Device Expiration Issue (1216)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/04/2016

Event Type  malfunction  

Event Description

It was reported an expired product was removed from hospital consignment.According to the reporting sales representative, prior to the assignment of a new field staff member to cover this hospital, he visited the facility to check inventory and located the product on the shelf.He removed the product from inventory.The newly assigned field representative will verify all expired product was removed.The reporting sales representative is sure this product was not implanted after expiration.

Manufacturer Narrative

Integra completed its internal investigation 4aug2016.The investigation included: method: review of device history records.Review of complaint management database for similar complaints.Results: the lot associated with this complaint is tg221 tenoglide tendon protector sheet, single 2in x 2in lot 105a00295782.The gtin for this product is (b)(4).All quality control analytical finished goods testing met the acceptance criteria.All quality control microbiology tests met their respective acceptance criteria.All in-process testing met specifications.Tenoglide has an expiration dating of 24 months from the date of manufacture.The expiration date assigned to lot 105a00295782 was 2015-12.The batch records include samples of labels used on the packaging of the product.All labels indicated the correct product name, lot number, and expiration date.All labels issued to this lot align with the expiration date of 2015-12.A query was performed for complaints issued from 16-jun-2015 to 16-jun-2016 and no additional complaints were found related to tenoglide products.Another query was performed searching for complaints regarding lot 105a00295782; no additional complaints were found.(b)(4).Conclusion: the unit of tenoglide described within this complaint was part of a sales representative¿s stock.Integra does not have a formal consignment agreement with (b)(6).The management of the unit of tenoglide was the responsibility of the sales representative.This unit was part of the rep¿s stock and it was kept at mt.Ogden surgical center as part of an agreement made with the sales representative.While an expired unit was found in inventory at (b)(6), the unit was not used.Integra currently has process steps in place to establish inventory maintenance.The unit also has the expiration date listed in multiple locations on the outer and inner packaging to ensure the hospital staff knows the date and that it is not used post expiration.

• Brand Name: TENOGLIDE TENDON PROTECTOR SHEET SINGLE 2IN X 2IN 5CM
• Type of Device: TENOGLIDE
• 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: 5761268
• MDR Text Key: 49390549
• Report Number: 1121308-2016-00014
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• PMA/PMN Number: K053655
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/16/2016

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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2015
• Device Catalogue Number: TG221
• Device Lot Number: 105A00295782
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2013
• 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