MAUDE Adverse Event Report: NEWDEAL SAS FULL TIBIAXYS SET; N/A

Catalog Number TIBIAXYSSET

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/13/2016

Event Type  malfunction  

Manufacturer Narrative

Integra has completed their internal investigation on 3nov2016.The investigation activities included: methods: evaluation of actual device.Review of device history records.Review of complaint management database for similar complaints.Results: dhr for loan set tibiaxys 007 reviewed and no anomalies that could be associated with the complaint were reviewed.A review of the complaint system was performed.This is the first incident reported to newdeal about a switch of tibiaxys and large qwix implants in the loan set tibiaxys for the past two years.The number of sets shipped to customers is taken into account.During the same time period, (b)(4) sets were shipped to customers.The complaint rate for this kind of incident during the stated time period is (b)(4) percent.Conclusion: the operator prepared many loan sets for shipment at the same time.There was confusion at the moment when he pasted the shipment's receipt on the container for tibiaxys and large qwix.The root cause is a human error and no check is performed to verify the address of shipment before the release of the loan sets.

Event Description

It is reported incorrect items were delivered within a loaner set to be used for a procedure.The customer booked a loan tibiaxys set for a surgery planned for (b)(6) 2016.The customer received tibiaxys loan set but inside the set were large qwix (set) implants instead of tibiaxys implants.The procedure was completed as planned because there were tibiaxys implants available on consignment.

• Brand Name: FULL TIBIAXYS SET
• Type of Device: N/A
• Manufacturer (Section D): NEWDEAL SAS; 97 allee alexandre borodine; 97 allee alexandre borodine; saint priest 69800 ; FR 69800
• Manufacturer (Section G): NEWDEAL SAS; 97 allee alexandre borodine; parc tech de laporte des alpes; saint priest 69800 ; FR 69800
• Manufacturer Contact: maria leonard ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6096952
• MDR Text Key: 60235537
• Report Number: 9615741-2016-00059
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: TIBIAXYSSET
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2016
• Date Manufacturer Received: 10/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1