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

Catalog Number 03.804.702S

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 05/17/2018

Event Type  malfunction  

Manufacturer Narrative

Patient height reported as 1.55m patient identifier is unknown.Additional procode: hrx.Device malfunctioned intra-operatively and was not implanted / explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter phone number and email address are unknown.The investigation could not be completed; no conclusion could be drawn, as no product was received.A device history records review has been requested.(b)(4).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

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that on (b)(6) 2018, balloon kyphoplasty was performed.The surgeon placed the access kit and wanted to perform the balloon through the trocar.This was not possible because the balloon did not go through the lumen of the trocar.Surgeon used a different access kit in the vertebral bodies, and this balloon showed an irregular shape.The surgeon stated that he has never before observed this with synflate devices.The lumen is different in both kits.One of the inner trocars does not fit into the outer trocar; therefore, the balloons could not be placed through the outer trocar.Intraoperatively, it turned out that vertebral bodies were osteoporotic.Needles could be introduced into the bone without hammering.Surgery was completed successfully, with a twenty (20) minute delay.Patient outcome is okay.This report is for a synflate balloon/large-sterile.This is report 1 of 4 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Additional narrative: device history record (dhr) review: part: 03.804.702s; lot: 0317125; manufacturing site: selzach; supplier: biotronik ag; release to warehouse date: may 23, 2017; expiry date: april 01, 2019.The device history record shows this lot of 25 pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, visual and functional criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.Investigation summary: the returned synflate l balloon was forwarded to the supplier evaluation.The statement below is a summary of their investigation.The complaint instrument was returned together with an access kit, including the working sleeve.The balloon of the complaint instrument is not well folded and has been inflated.The returned working sleeve was inspected and has obviously been used.Due to the state of the complaint instrument the system profile could not be assessed.Functional testing was performed by connecting an inflation device filled with water to the hub of the complaint instrument.The balloon could be normally inflated, but an irregular shape was noted.Unfortunately the balloon burst, before this shape could be documented with a camera.However, simulations with a reference synflate l balloon were conducted in a water bath at 37°.The reference balloon was normally inflated with its distal end being partially inside a glass model with an inner diameter of 9 mm, mimicking a complex hard vertebral body.The simulations showed that after removal from the model the balloon of the reference balloon had a similar shape to what was observed in the complaint instrument.The physician reported difficulties in passing the complaint instrument through the working sleeve.After utilization of different access kits the balloon could be delivered to the affected vertebral body.Upon inflation an irregular shape of the balloon was noticed.Review of the manufacturing history of the production lot did not reveal any nonconformity.The complaint instrument was manufactured according to specifications and successfully passed all in-process inspections as well as the final inspection.The technical investigation revealed that the balloon of the complaint instrument is not well folded and has been inflated.Due to the state of the device the system profile of the complaint instrument could not be assessed.During the lot release inspection the profile of a subset of the instruments in the lot is assessed.During this test the instrument is pushed into a cannula and the force to do so is assessed.The complaint lot complies with the specification.However, based on the physician's description it appears that the issues in delivering the complaint instrument to the affected vertebral body are related to the working sleeve.The accessory kit is not manufactured by biotronik ag.During the technical investigation functional testing was performed.The balloon could be normally inflated, but an irregular shape was noted.Simulations with a reference synflate l revealed that an inflation of a balloon inside a complex hard structure (e.G.Vertebral body) can result in an irregular balloon shape as observed by the physician.The root cause for the complaint event is therefore most likely related to the patient's anatomy.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.The subject device has been received by the manufacturer and is undergoing investigation.The results of the investigation are pending completion and will be submitted in a supplemental report.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/LARGE-STERILE
• Type of Device: POLYMETHYLMETHACRYLATE BONE CEMENT
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7598293
• MDR Text Key: 111026039
• Report Number: 8030965-2018-54321
• Device Sequence Number: 1
• Product Code: NDN
• UDI-Device Identifier: 07611819525405
• UDI-Public: (01)07611819525405
• Combination Product (y/n): N
• PMA/PMN Number: K130146
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• 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: 03.804.702S
• Device Lot Number: 0317125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2018
• Date Manufacturer Received: 09/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 56