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

Catalog Number XXX-PANTA NAIL

Device Problems Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Neuropathy (1983); Skin Irritation (2076); Impaired Healing (2378)

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 numbers: 9615741-2018-00062; 9615741-2018-00063; 9615741-2018-00065; 9615741-2018-00066.

Event Description

The bone & 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) two screws in two different patients had to be removed postoperatively because of skin irritation: a calcaneal screw and a proximal fixation screw.The patient, who underwent removal of the proximal screw, had a prolonged vacuum assisted closure on the distal medial tibia for delayed wound healing and superficial infection.Screw removal did not affect nail stability.Additional information has been requested to the author.

Manufacturer Narrative

Additional information was requested to the author, the following was received: patient: female, (b)(6) years old.Fusion level: left hindfoot.Date of initial procedure: (b)(6) 2015.Follow-up: 10 months.

Manufacturer Narrative

Integra has completed their internal investigation: as products were not returned, no failure analysis was performed.As dhr review and failure analysis could not be performed, root cause cannot be determined.A review and comparison of surgical technique was performed and a review of the post-operative recommendations was performed.In conclusion, these revues do not highlight any improper gesture or improper post-operative follow up.A review of the current ¿instruction for use¿ was performed.In conclusion: preoperative risk factors, etiology and frequent adverse event are mentioned in ifu.

• 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: 7488044
• MDR Text Key: 107400499
• Report Number: 9615741-2018-00064
• 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: 05/18/2018
• 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