MAUDE Adverse Event Report: SYNTHES SELZACH SYNFLATE BALLOON/MEDIUM-STERILE; POLYMETHYLMETHACRYLATE BONE CEMENT

Catalog Number 03.804.701S

Device Problems Break (1069); Material Puncture/Hole (1504)

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

Event Date 02/11/2016

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: additional device product code is hrx.(b)(4).A product development investigation and device history record review were performed for the subject device (medium synflate balloon, part number, 03.804.701s, lot number 0515013).The returned subject device was examined and dried blood could be seen trapped in the balloon indicating that there is indeed a puncture in the balloon.The synflate balloon/medium (03.804.701s) is a component of the synflate system which is a balloon-based vertebral augmentation system utilized for vertebral compression fractures and osteolytic lesions.The system technique guide notes the following regarding balloon inflation: proceed with inflation slowly, stopping every few seconds to allow the bone to adjust to the pressure/volume changes; the balloons may leak or burst if they are filled beyond their maximum volume or pressure.Relevant drawings for the returned devices were reviewed.The design and materials were found to be appropriate for the intended use of these devices.A device history record review was performed for the subject device lot.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.No definitive root cause was able to be determined based on the complaint description.Burst balloons are often related to inflation technique or contact with sharp biology.The complaint is confirmed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was initially reported that on (b)(6) 2016, the patient underwent surgery for a l3 compression fracture (not >50%) with 2 mm of mild retropulsion.During the procedure the surgeon inserted the balloon into the working cannula and began to inflate the balloon.The pressure never reached above 220psi and was only filled with approximately 2ml of contrast solution when the inflation device registered a loss of pressure.The surgeon removed the balloon from the working cannula and re-inflated it over a mayo stand (table) to determine if the balloon was intact.Upon re-inflating the balloon additional contrast solution was injected into the balloon during testing and it was discovered that a very tiny hole was leaking the contrast.This hole is what has caused the loss of pressure in the inflation device.It did not appear that any balloon fragments were missing due to the hole.As a result of this event a surgical delay of five minutes was reported.A similar device was available for the surgeon to successfully compete the procedure.It was reported that the patient¿s condition was stable after the procedure.This event was evaluated based on provided information the device was not considered to have broken intraoperatively at that time.The complained device was returned to the manufacturer for investigation.Upon investigation dried blood was observed trapped in the balloon, indicating that there is indeed a puncture in the balloon.Based on this observation, it was determined that this device broke intraoperatively.The event was re-evaluated on (b)(4) 2016 and it was determined that the event is reportable due product malfunction.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device is an instrument and is not implanted or explanted.The lot number contained within the text of the device history records on the initial medwatch was incorrectly reported as (b)(4).The correct lot number for the device, which corresponds with that dhr review, is (b)(4).Device 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: SYNFLATE BALLOON/MEDIUM-STERILE
• Type of Device: POLYMETHYLMETHACRYLATE BONE CEMENT
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer (Section G): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5540933
• MDR Text Key: 41681643
• Report Number: 3000270450-2016-10083
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2017
• Device Catalogue Number: 03.804.701S
• Device Lot Number: 0915025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 74 YR