MAUDE Adverse Event Report: NEWDEAL SAS ADVANSYS UNKNOWN; N/A

Catalog Number XXX-ADVANSYS

Device Problem Insufficient Information (3190)

Patient Problems Cellulitis (1768); Skin Erosion (2075)

Event Type  Injury  

Manufacturer Narrative

The device involved in the reported incident is not available for evaluation.An investigation has been initiated based on the reported information.Other mgf report numbers: 9615741-2018-00039, 9615741-2018-00040, 9615741-2018-00042.

Event Description

Three of 4 reports: the foot and ankle international journal ( 2017) published ¿ comparison of posterior approach with intramedullary nailing versus lateral transfibular approach with fixed-angle plating for tibiotalocalcaneal arthrodesis¿.The purpose of this study was to compare the results of tibiotalocalcaneal ( ttc ) arthrodesis with either a posterior, achilles tendon-splitting (pats) approach with intramedullary (im) nailing or lateral, transfibular (ltf) approach with fixed-angle plating.Sixty-six patients were identified, thirty-eight underwent ttc arthrodesis through a pats approach with im nailing and 28 underwent the same procedure through an ltf approach and fixed-ankle plating.Four patients had superficial wound breakdown and cellulitis that cleared with local wound care and oral antibiotics.Additional information was requested to the author.However, no further information is available.

Manufacturer Narrative

The device was not returned for evaluation.As no product id and no manufacturing lot number was provided to integra, no device history record (dhr), design specification or design change record will be performed.A review of the current instruction for use was performed.In conclusion, preoperative risk factors and etiology of this group are mentioned in ifu.Also, as product was not returned, no failure analysis was performed.The root cause is not determined but, physical condition, preoperative risk factors and etiologies of the patients might be reason of infection.Moreover, there is a low risk that the packaging of products involved in these incidents did not provide the level of sterility intended.

• Brand Name: ADVANSYS UNKNOWN
• 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: vivian nelson ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 7287355
• MDR Text Key: 100645622
• Report Number: 9615741-2018-00041
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: K063820
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: XXX-ADVANSYS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention