MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SYNFLATE BALLOON/MEDIUM- STERILE; SYNFLATE VERTEBRAL BALLOON MED

Model Number 03.804.701S

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/01/2018

Event Type  malfunction  

Manufacturer Narrative

Additional classification code: hrx.Implant and explant dates: device is an instrument and is not implanted/explanted.A device history record review was requested.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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.

Event Description

It was reported that during a spine procedure on (b)(6) 2018, an incident occurred when the surgeon was inserting balloon into the left side of l1 after already inflating/deflating balloon bilaterally in l2.The balloon became lodged inside the cannula and pulled entire piece dangerously close to the anterior wall.When surgeon rapidly pulled balloon back, the entire cannula came out of the patient.In addition, factors that could have contributed to this situation include: scrub technicians contrast on the gloves may have transferred to the outside of balloon when, in between uses, when he removed excess air (using the synthes syringe include in the synflate packaging) to recreate vacuum.Also, the inflation device was not properly recalibrated between uses - even though the leading edge of red ring was advanced to zero each time, air bubbles remained lodged in the line and may have had an impacted the effectiveness/safety of the system.The surgery was completed by replacing the balloon and the inflation systems.There was no reported patient consequence.Concomitant device reported: unknown cannulated trocar sleeve (part number unknown, lot number unknown, quantity 1).This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Device history records review was completed for part# 03.804.701s, lot# 0117009.Manufacturing location: selzach, release to warehouse date: feb 14, 2017, expiry date: dec 31, 2018.No non- conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Product development investigation was completed.The synflate balloon (part 03.804.701s, lot 0117009, manufactured on feb 14, 2017) was received at us customer quality.No defects or deficiencies were identified during a visual examination which could have contributed to the reported complaint condition.The cannula was not returned, so replication could not be attempted.Based on the reported complaint description, surgical technique (using the balloon three times rather than the single use recommended in the technique guide) is likely contributed to the complaint condition.Drawing review and dimensional analysis is not applicable as the complaint condition is likely a result of method of use.The synflate balloon system is intended to be used twice (bilaterally) outside the united states, and once within the us.Relevant technique guides synflate vertebral balloon and synflate address these use indications.This complaint describes the balloon being used three times.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.There is no indication that a design or manufacturing issue contributed to the complaint.No new malfunctions were observed during this investigation.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.These dates were incorrectly reported as 3/1/2018 in the initial report.The correct date is 3/2/2018.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: SYNFLATE BALLOON/MEDIUM- STERILE
• Type of Device: SYNFLATE VERTEBRAL BALLOON MED
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7386833
• MDR Text Key: 104157456
• Report Number: 2939274-2018-51368
• Device Sequence Number: 1
• Product Code: NDN
• UDI-Device Identifier: 10705034722719
• UDI-Public: (01)10705034722719(17)20181231(10)0117009
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130146
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Model Number: 03.804.701S
• Device Catalogue Number: 03.804.701S
• Device Lot Number: 0117009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2017
• 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
• Patient Age: 76 YR
• Patient Weight: 68