MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA CARPAL POLY, LARGE - STD.; UNI2 TOTAL WRIST IMPLANT SYSTEM

Catalog Number 262400

Device Problem Protective Measures Problem (3015)

Patient Problem No Patient Involvement (2645)

Event Date 01/19/2016

Event Type  malfunction  

Manufacturer Narrative

Integra completed its internal investigation 21dec2015.The investigation included: method: review of device history records.Review of complaint management database for similar complaints.Results: there were no material non-conformances or variances associated with this lot of implants.A query in the complaint database did not identify other customer complaints associated with a reported distribution of expired universal2 total wrist implants.The query was limited to the time frame of 2012 to 2015 year to date.The five complaints associated with the distribution of expired implants are the only ones associated with the universal2 total wrist system.A review of sales figures determined that (b)(4) individual universal2 implants were sold worldwide from (b)(4) 2012 to (b)(4) 2015.The shipment of five expired implants results in a failure rate of (b)(4).Conclusion: based on the information that was provided from the complainant, integra was able to confirm that expired product was shipped from integra (b)(4) to a hospital.An investigation conducted by integra (b)(4) quality assurance and regulatory affairs identified the root cause as a breakdown in the inspection process for the release of product to the field.Integra (b)(4) initiated a capa to address this issue.

Event Description

This is report 2 of 5 for the same product issue.Mfr.Numbers for the 5 reports: 3004608878-2015-00289; 3004608878-2016-00017; 3004608878-2016-00018; 3004608878-2016-00019; 3004608878-2016-00020.It was reported that after a procedure where expired product was implanted, the sales representative went through the remaining stock and found a number of other implants which were also expired.

• Brand Name: CARPAL POLY, LARGE - STD.
• Type of Device: UNI2 TOTAL WRIST IMPLANT SYSTEM
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer Contact: maria leonard ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5378377
• MDR Text Key: 36351627
• Report Number: 3004608878-2016-00017
• Device Sequence Number: 1
• Product Code: JWJ
• Combination Product (y/n): N
• PMA/PMN Number: K030037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 262400
• Device Lot Number: 087664
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2010
• 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