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

Catalog Number XXX-PANTA NAIL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Injury (2348); Ambulation Difficulties (2544)

Event Type  Injury  

Manufacturer Narrative

The device will not be returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.The online version of the article can be found at: http://dx.Doi.Org/10.1053/j.Jfas.2016.06.002.

Event Description

The journal of foot and ankle surgery (2016) published: "minimally invasive surgery for tibiotalocalcaneal (tcc) arthrodesis using a retrograde intramedullary nail: preliminary results of an innovative modified technique".The aim of the present longitudinal prospective study was to evaluate the clinical, functional, and radiologic outcomes and patient satisfaction of those who had undergone minimally invasive surgery (mis) for tibiotalocalcaneal arthrodesis with an intramedullary nail.The twenty eight (28) patients who had consecutively undergone surgery with the mis technique were evaluated clinically and radiographically at 1, 2, 3, and 6 months after surgery and at last follow-up examination.The participants included 22 males and 6 females, with an age range 35 to 80 years and a mean weight of 47 to 138 kg at surgery.Of the 28 patients, 12 were affected on the right foot and 16 on the left foot.All ttc fusions were performed using a retrograde intramedullary titanium (ti-6ai-4v) nail (panta nail).Results: one patient had delayed radiologic consolidation with associated pain.One patient experienced abnormal ambulation but none had severe restriction of daily activities.At the latest follow-up point, two (2) patients reported persistent pain.Screw protrusion was observed in one (1) case and exostosis in three (3) patients.Improper alignment of the hindfoot was detected in one (1) patient who had experienced significant bone loss.The foot was fused in equinus by the surgeon, owing to the lack of bone.No issues related to surgical wounds developed.Conclusion: the preliminary data have demonstrated that this combined technique consisting of minimally invasive surgery for debridement of articular surfaces, associated with the use of a compressive retrograde intramedullary nail, allows successful and safe achievement of the clinical and radiologic goals of a stable and early ttc arthrodesis, thus minimizing the occurrence of the common complications of traditional procedures.Additional information has been requested from the author.

Event Description

N/a.

Manufacturer Narrative

As no part number or manufacturing lot number was provided no design change or dhr review could be performed.As products were not returned, no failure analysis could be performed.As dhr review and failure analysis could not be performed, root cause cannot be determined.

• 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
• MDR Report Key: 7648091
• MDR Text Key: 112707752
• Report Number: 9615741-2018-00084
• 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: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 06/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• 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
• Date Manufacturer Received: 07/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention