MAUDE Adverse Event Report: SYNTHES USA 1.6MM NON-THREADED GUIDE WIRE TROCAR POINT 220MM; PIN,FIXATION,SMOOTH

Catalog Number 02.226.001

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 11/17/2015

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient information not provided by reporter.Device is not expected to be returned for manufacturer review/investigation.(b)(6).Subject device has not been received.Without a lot number, the device history record review and the investigation could not be completed; due the insufficient information¿s.No conclusion could be drawn, no further investigation possible as there was no material available.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Report from synthes europe reports an event in (b)(6) as follows:procedure: it was reported that a ankle fusion.1.6mm wire (#2) bent in situ within patient's talus following contact with another wire (#1) already in situ.When surgeon drilled over wire #1 it came into contact with wire #2 and broke wire #2 into two pieces.The far end of the wire that was broken in situ was able to be retrieved from the patient by an extra surgical incision.Patient outcome post-surgical procedure: unknown - no adverse effect expected.10 minutes delay in surgery.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

(b)(4).Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 1.6MM NON-THREADED GUIDE WIRE TROCAR POINT 220MM
• Type of Device: PIN,FIXATION,SMOOTH
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5290804
• MDR Text Key: 33323835
• Report Number: 2520274-2015-17718
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK080943
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/17/2015

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: 02.226.001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/17/2015
• Initial Date FDA Received: 12/11/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention