MAUDE Adverse Event Report: NEWDEAL SAS PANTANAIL DEVICE - UNSPECIFIED; PANTA NAIL

Catalog Number XXX-PANTA NAIL

Device Problems Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

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.Linked to mfg report number: 9615741-2018-00063, 9615741-2018-00064, 9615741-2018-00065, 9615741-2018-00066.

Event Description

The bone and joint journal (2018) published: "mid-term follow-up of patients with hindfoot arthrodesis with retrograde compression intramedullary nail in charcot neuropathy of the hindfoot".The purpose of this study is to evaluate the mid-term outcome of hindfoot reconstruction in terms of union, function, alignment, and complication rate in patients with deformity of the ankle secondary to charcot arthropathy presenting with or without ulcers, with the major endpoint being the rate of limb salvage.A total of 18 patients (19 feet) with an advanced degree of ankle and subtalar joint instability and/or deformity were operated on during the study period (january 2011 to june 2013).In three limbs, amputation had to be performed due to persisting infection and osteomyelitis resistant to parenteral antibiotic therapy and repeated debridement.All amputees were initially poor hosts in terms of general health and immunity status.All of them had preoperatively presented with infected sole ulceration.Two of them were diabetic patients and one was a heavy smoker with established peripheral vascular disease.Additional information has been requested to the author.

Manufacturer Narrative

Integra has completed their internal investigation: as no product id and no manufacturing lot number was provided to integra, no dhr, design specification or design change record will be performed.No failure analysis was performed, product was not returned.The root cause is not determined but, physical condition, preoperative risk factors and etiologies of the patient might be reason of amputation.Indeed, as mentioned in clinical evidence report, comorbidities such as diabetes and charcot arthropathy as well as preoperative ulcers pose a higher risk of amputation.

Manufacturer Narrative

Additional information was requested to the author, the following was received:: patient: (b)(6) years old, male.Fusion level: hindfoot and midfoot; left side.Date of initial procedure: (b)(6) 2014.Follow-up: 13 months.The literature reports 3 amputations; however, based on additional information received, intgera panta nail was implanted in 2 of the 3 amputations.A competitor implant was used in the other amputation case.This report is linked to mfg report number: 9615741-2018-00067.

• Brand Name: PANTANAIL DEVICE - UNSPECIFIED
• Type of Device: PANTA NAIL
• 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: sonia irizarry ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 7487844
• MDR Text Key: 107386185
• Report Number: 9615741-2018-00062
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K091788
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: XXX-PANTA NAIL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/23/2018
• 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): Disability