MAUDE Adverse Event Report: NEWDEAL SAS K-WIRE 10/10 - LENGTH 70 MM

Catalog Number 115070

Device Problem Material Fragmentation (1261)

Patient Problems Rheumatoid Arthritis (1724); Device Embedded In Tissue or Plaque (3165)

Event Type  malfunction  

Event Description

This is the second report of two reports regarding the same pt.This report concerns the k-wire.It was reported "the thing is that for two year ago a bold (screw) was put in a patent for arthrodesis.This was done with help of a k-wire.But by some reason the k-wire tip was 'last' in the bold screw so they leave it.And today the pt was a rheumatoid problematic (sic) and the rheumatoid doctor want to know what quality the wires is made of.Can this be the effective or something.Numerous attempts have been made to obtain additional information.

Manufacturer Narrative

The device involved in the reported incident is not available for evaluation.An investigation has been initiated based on the reported information.

• Brand Name: K-WIRE 10/10 - LENGTH 70 MM
• Type of Device: NA
• Manufacturer (Section D): NEWDEAL SAS; saint priest 6980 0; FR 69800
• Manufacturer Contact: caren finkelstein ; 315 enterprise drive; plainsboro, NJ 08536 ; 6099362341
• MDR Report Key: 3829379
• MDR Text Key: 4405458
• Report Number: 9615741-2014-00008
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 115070
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/27/2014
• Initial Date FDA Received: 03/18/2014
• 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