MAUDE Adverse Event Report: SYNTHES SELZACH SYNFLATE VERTEBRAL BALLOON MED; POLYMETHYLMETHACRYLATE BONE CEMENT

Catalog Number 03.804.701S

Device Problem Fitting Problem (2183)

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

Event Date 09/05/2017

Event Type  malfunction  

Manufacturer Narrative

Device used for treatment, not diagnosis.Patient information not available for reporting.Additional classification code: hrx.(b)(4).Device malfunctioned intra-operatively and was not implanted / explanted.Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received.Reporters phone number: (b)(6).Device history records review was conducted.The report indicates that the: part #03.804.701s / lot #0317053.Manufacturing location: (b)(4).Supplier: (b)(4).Manufacturing date: 04.May 2017 expiry date: 01.April 2019.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes on an event in (b)(6) as follows: it was reported that during kyphoplasty the synflate vertebral balloon was leaking.The contrast agent ran out and could not be dilated in the vertebral body.The surgery was prolonged about 10 minutes.Patient outcome is ok.There was no patient harm.They used another synflate to complete the surgery.The procedure was successful.This complaint involves 1 part.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Date returned to manufacturer.Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.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.

Manufacturer Narrative

A manufacturing investigation action was conducted/performed.The report indicates that: the complained article has been forwarded to the manufacturing site and are now in the receipt of the investigation results.The complaint instrument returned with the protector being partially applied to the balloon.Blood residue was observed between the protector and the balloon.In the as-returned state the protector was stuck on the balloon.It seems likely that the protector has been re-applied to the balloon.The distal end of the balloon is pushed in distal direction with air inside the balloon lumen.To be able to remove the protector, the device without causing damage the instrument was put in decontamination liquid for 24 hours.After successful removal of the protector functional testing was performed by connecting a medtronic everest inflation device filled with water to the hub.Positive pressure was applied and the balloon normally at about 2-3 atm.No leakage was apparent and the balloon could also be deflated normally.Inspection of the remainder of the device revealed no other damage or irregularities.It was therefore not possible to reproduce the reported problem.The physician reported that during a kyphoplasty the balloon of the complaint instrument was leaking and could thus not be dilated in the vertebral body (i.E.Inside patient).Review of the manufacturing history of the production lot did not reveal any nonconformity considered being relevant in light of the complaint.The complaint instrument was manufactured according to the specifications and successfully passed all in-process inspections as well as the final inspection including a leakage test.The complaint instrument was returned without the inflation device used during the procedure.In the as returned condition the protector was stuck on the balloon, and residue of dried blood was observed between the balloon and the protector.During the technical investigation it was possible to in- and deflate the balloon normally.No leakage was apparent.The reported problem could thus not be reproduced.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 VERTEBRAL BALLOON MED
• 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6896079
• MDR Text Key: 88267086
• Report Number: 3000270450-2017-10339
• Device Sequence Number: 1
• Product Code: NDN
• 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,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2019
• Device Catalogue Number: 03.804.701S
• Device Lot Number: 0317053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1