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

Catalog Number 115070ND

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/30/2016

Event Type  malfunction  

Manufacturer Narrative

Integra has completed their internal investigation on (b)(6) 2016.The investigation activities included: evaluation of actual device.Review of device history records.Review of complaint management database for similar complaints.Unable to review dhr as lot number was unavailable.A review of the complaint system was performed.This is the first incident reported to newdeal about torn k-wire during last two years.During the same time period, 66725 k-wires were sold.The complaint rate for this kind of incident during the stated time period is 0.0014 percent.Given the description of the event and the impossibility to perform a documentary investigation, the root cause cannot be determined.

Event Description

A torn/bent k wire was returned with a screw in regard to a customer complaint.It is reported the device was in contact with the patient; however, no patient injury is alleged.

• Brand Name: K-WIRE 10/10 LENGTH 70 MM
• Type of Device: ORTHO FIXATION
• 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: maria leonard ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6095741
• MDR Text Key: 59752826
• Report Number: 9615741-2016-00058
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• PMA/PMN Number: K022599
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/19/2016

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: 115070ND
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/19/2016
• Initial Date FDA Received: 11/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: BOLD SCREW LG 16MM STERILE / 111016SND / FFP7