MAUDE Adverse Event Report: SYNTHES GMBH SYNFLATE BALLOON/SMALL- STERILE; CEMENT, BONE, VERTEBROPLASTY

Catalog Number 03.804.700S

Device Problem Inflation Problem (1310)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Additional device product code: hrx.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 reports an event in (b)(4) as follows: it was reported that before the intervention the balloon was tested and it was not possible to fill it.The liquid ran out instantly without ever reaching the balloon.There was a twenty (20) minutes surgical delay due to the reported event.Action taken when event occurred was kyphoplastie bwk 6.The procedure was successfully completed.There was no patient consequence.This report is for one (1) synflate balloon/small- sterile.This is report 1 of 1 for complaint (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.The device was not returned.A photo-investigation was performed on the video.Upon inspecting all the images provided under notes & attachments section, it is observed that the video doesn't show the complete device to confirm whether it can be inflated or deflated but we have observed leakage of the fluid which might be due to the crack in the synflate vertebral balloon sm, hence conforming the allegation.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The complaint condition can be confirmed during photo/video investigation.During the investigation, no product design issues or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.Device history lot : part # 03.804.700s.Synthes lot # h884711.Supplier lot # h884711.Release to warehouse date: 24 jan 2020.Expiration date: 01 dec 2021.Supplier: (b)(4).No ncr's were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Photo investigation: the device was not returned.A photo-investigation was performed on the video "(b)(4)" located in pc under notes & attachments section.Upon inspecting all the images provided under notes & attachments section, it is observed that the video doesn't show the complete device to confirm whether it can be inflated or deflated but we have observed leakage of the fluid which might be due to the crack in the synflate vertebral balloon sm, hence conforming the allegation.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.Visual inspection: the complaint device synflate vertebral balloon sm (product code: 03.804.700s, lot number: h884711) was returned to cq west chester for investigation.The catheter for the synflate balloon had a issue with the holes near the luer lock area.This item was forwarded to the supplier confluent medical technologies for further evaluation and this investigation is based on the report from confluent ¿complaint (b)(4) depuy synflate s leakage will not inflate or deflate (b)(4).Functional test: the catheter for synflate system leaked leading to the balloon not inflating/deflating during test.Dimensional inspection: this was not performed as the issue was identified to be the incorrect sealing of the holes.Document/specification review: based on the date of manufacture, the current and manufactured to version of drawing were reviewed.Inner tray assembly synflate, (b)(4) (current and manufactured).Manifold, (b)(4) (current and manufactured).Manifold, (b)(4) (current and manufactured).Conclusion: the device leaked during use due to the improper sealing of the holes in the manifold during manufacturing.Since this was found to be an operator error as a part of corrective actions, the operators were retrained, and the document is attached here.Also, as preventive actions during leak test, ordering of bins based on the test performed will be done and a clear instruction for the luer hub bonding inspection will be updated on the work instruction.The lot number under investigation expired on 01-dec-2021, hence this issue was not escalated at the manufacturer.A jnj nc (b)(4) was initiated for this confirmed issue.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot - no ncr's were generated during production.Device history review - review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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/SMALL- STERILE
• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 12548850
• MDR Text Key: 278148846
• Report Number: 8030965-2021-08136
• Device Sequence Number: 1
• Product Code: NDN
• UDI-Device Identifier: 07611819525382
• UDI-Public: (01)07611819525382
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K130146
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2021
• Device Catalogue Number: 03.804.700S
• Device Lot Number: H884711
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1