MAUDE Adverse Event Report: SYNTHES USA 1.1MM THREADED GUIDE WIRE 150MM

Catalog Number 292.622

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem No Code Available (3191)

Event Date 01/10/2014

Event Type  malfunction  

Manufacturer Narrative

This device was used for treatment, not diagnosis.The investigation could not be completed; no conclusion could be drawn, as no product was received and without a lot number the device history records review could not be completed.Placeholder.

Event Description

It was reported that the k-wire was inserted and the surgeon attempted to drill with the cannulated drill bit over the wire.When he pulled drill bit out, a fragment of the k-wire was stuck in the patient.It was reported that all broken fragments were retrieved; there was a delay of 15 minutes in completing the procedure.The procedure was successfully completed and there was no harm to the patient.This is report one of one for complaint (b)(4).

• Brand Name: 1.1MM THREADED GUIDE WIRE 150MM
• Manufacturer (Section D): SYNTHES USA; west chester PA
• Manufacturer Contact: vera wirawan ; 1302 wrights lane east; west chester, PA 19380 ; 8006207025
• MDR Report Key: 3600698
• MDR Text Key: 21271360
• Report Number: 2520274-2014-00350
• Device Sequence Number: 1
• Product Code: FZX
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 292.622
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Age: 19 YR