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

Catalog Number 02.226.001

Device Problem Failure to Align (2522)

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

Event Date 06/06/2014

Event Type  Injury  

Event Description

It was reported that during a fusion procedure a 4.5mm headless compression screw unraveled at the threads and a k-wire that was pushing through the joint was removed.Surgeon used an osteotome to remove broken hardware.The surgeon was able to retrieve all pieces.There was a surgical delay reported of twenty minutes.This report is 2 of 2 for complaint (b)(4).

Manufacturer Narrative

Device used for treatment, not diagnosis investigation could not be completed and no conclusion could be drawn as no device was returned and no lot number was provided.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 BALSTHAL; dornacherstrasse 20; balsthal CH47 10; SZ CH4710
• Manufacturer (Section G): SYNTHES BALSTHAL; dornacherstrasse 20; balsthal CH47 10; SZ CH4710
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 3912886
• MDR Text Key: 17386269
• Report Number: 3009450863-2014-10016
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2014
• 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
• Date Manufacturer Received: 06/06/2014
• 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
• Patient Age: 72 YR
• Patient Weight: 86