MAUDE Adverse Event Report: SYNTHES BALSTHAL GUIDEWIRE Ø1.1 W/THREAD-TIP W/TROCAR L15

Catalog Number 292.622S

Device Problem Break (1069)

Patient Problem Sedation (2368)

Event Date 03/04/2014

Event Type  Injury  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that the patient had an avulsion fracture of epicondylus medialis humeri and underwent the surgery using with cancellous cervical spacer 3.0mm manufactured by synthes.Surgical incision and reduction was performed without any trouble, when the doctor tried to insert the guide wire in question it was reported that it was impossible to insert.The cause might be that the bone quality was good.Surgeon continued and the guide wire broke at approximately 5mm from the cortical bone.The surgeon tried to hold with pliers the front part of guide wire and pull for picking the residual guide wire from the bone, but it broke again at about 5mm from the cortical structure.Eventually full 30cm from the tip of guide wire was left in the bone.Surgeon tried to ream around the guide wire by using drill bit in manner of using with halo reamer.Nevertheless the front of cortical structure could not be drilled and the drill bit broke.Conclusively the surgeon used the drill bit for cancellous cervical spacer 4.0mm by a different manufacturer instead of halo reamer, and was able to remove of the fragmented guide wire.An 80 minute surgical delay was reported.This is report 1 of 2 for complaint (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records was performed and no complaint related issues were found.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: GUIDEWIRE Ø1.1 W/THREAD-TIP W/TROCAR L15
• Type of Device: GUIDE
• 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: 3695615
• MDR Text Key: 4253755
• Report Number: 3009450863-2014-10003
• Device Sequence Number: 1
• Product Code: HXI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/04/2014

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 Expiration Date: 01/01/2020
• Device Catalogue Number: 292.622S
• Device Lot Number: 3326731
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/04/2014
• Initial Date FDA Received: 03/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2009
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention