MAUDE Adverse Event Report: NEWDEAL S.A.S. DEVICE FOR NAIL FIXATION; PANTA NAIL

Catalog Number 519110ND

Device Problem Failure to Align (2522)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Event Description

It was reported the physician had issues with the nail and the targeting jig lining up.Revision or medical intervention was required."we were able to make it work but this loaner pool set from odc needs to be looked upon return.We had to start drilling in the tibia and mallet the ends of the drill bits to make them find the holes on the nail - for compression rods and static locking screws (tibia)".

Manufacturer Narrative

It is unk if the device involved in the reported incident is expected to be returned for evaluation.An investigation has been initiated based upon the reported info.

• Brand Name: DEVICE FOR NAIL FIXATION
• Type of Device: PANTA NAIL
• Manufacturer (Section D): NEWDEAL S.A.S.; saint priest 6980 0; FR 69800
• Manufacturer Contact: maria leonard ; 315 enterprise dr; plainsboro, NJ 08536 ; 6099362341
• MDR Report Key: 4360425
• MDR Text Key: 5111742
• Report Number: 9615741-2014-00066
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091788
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 519110ND
• Device Lot Number: PANTA TRAY PANTXL-051
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1