MAUDE Adverse Event Report: NEWDEAL SAS AO DRILL 2 IN 1 DIAM 2.2MM L 32MM CANNULATED; N/A

Catalog Number 159023SND

Device Problem Device Markings/Labelling Problem (2911)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 12/07/2015

Event Type  malfunction  

Event Description

It was reported there was an issue with labeling on a product.Product identification information on the external package was different from the product identification on the internal package.No complaint circumstance or patient impact information was provided.Additional information has been requested.

Manufacturer Narrative

Integra completed its internal investigation 26jan2016.The investigation included: method: review of device history records.Review of complaint management database for similar complaints.Results: a review of the device history record is done for manufacturing lot fbyd reported in this incident.The manufacturing lot fbyd was manufactured in october 2015.Copies of the labels included in the dhr are in compliance with specifications.It was the first batch manufactured following new specifications (including udi requirements).Labels were printed internally.It was discovered that a first print of 5 labels kits was done to allow validation of the labels and complete integra dhr and supplier dhr.Then, once validated, a second print was launched.The error happened during the second print where part number was incorrect.The error was not detected.This process of edition by two prints was done only for the first packaging / labelling (b)(4).A review of all batches for this packaging / labelling order is done to check the labels and no other anomaly was found.In conclusion, the issue is confirmed and limited to lot fbyd.A review of the complaint system was performed.This is the first incident was found about an incorrect part number on labels for the past two years.(b)(4).Conclusion: given the description of the event and the observations made during the documentary investigation, the root cause is a human error occurred during internal edition of the label.No procedure is available for this process.A non-conformance was initiated in order to analyze this issue and take appropriate actions.

• Brand Name: AO DRILL 2 IN 1 DIAM 2.2MM L 32MM CANNULATED
• 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: 5346650
• MDR Text Key: 35611234
• Report Number: 9615741-2015-00068
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 12/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 159023SND
• Device Lot Number: FBYD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2015
• 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