MAUDE Adverse Event Report: NEWDEAL SAS DEVICE FOR NAIL FIXATION; PANTA NAIL

Catalog Number 519110ND

Device Problems Mechanical Problem (1384); Sticking (1597)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/17/2014

Event Type  malfunction  

Event Description

This is the first of two reports.This report concerns the device for nail fixation (b)(6).It was reported that during surgery, the metallic compression device did not enter easily in the plastic support after insertion of calcaneal screws.The surgeon used 'liquid vaseline' to lubricate the device and easily insert the device in the plastic support.Surgery time was increased by 5 minutes.There was no injury or adverse consequence reported.

Manufacturer Narrative

The device involved in the reported incident has been received for evaluation.An investigation has been initiated based on the reported information.

• Brand Name: DEVICE FOR NAIL FIXATION
• Type of Device: PANTA NAIL
• Manufacturer (Section D): NEWDEAL SAS; saint priest 6980 0; FR 69800
• Manufacturer Contact: caren finkelstein ; 315 enterprise dr; plainsboro, NJ 08536 ; 6099362341
• MDR Report Key: 3901784
• MDR Text Key: 19297779
• Report Number: 9615741-2014-00022
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K091788
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 519110ND
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/17/2014
• Initial Date FDA Received: 05/08/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 70 YR