MAUDE Adverse Event Report: SYNTHES USA SYNFLATE BALLOON/LARGE- STERILE; POLYMETHYLMETHACRYLATE BONE CEMENT

Catalog Number 03.804.702S

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 06/13/2013

Event Type  malfunction  

Event Description

It was reported that during cadaver lab demonstration, a sales team member leading the demonstration proceeded to prep the a pedicle using the drill provided in the synflate access kit after large synflate balloon was inserted into the pedicle.During this process, the large synflate balloon that had already been placed was inadvertently ruptured by the drill by the sales team member.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional product code: hrx.Without a lot number the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SYNFLATE BALLOON/LARGE- STERILE
• Type of Device: POLYMETHYLMETHACRYLATE BONE CEMENT
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4565184
• MDR Text Key: 5551261
• Report Number: 2520274-2015-11396
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK130146
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/20/2015

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: 03.804.702S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/20/2015
• Initial Date FDA Received: 03/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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