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

Catalog Number 03.804.701S

Device Problems Inflation Problem (1310); Compatibility Problem (2960)

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

Event Date 11/21/2023

Event Type  malfunction  

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.D9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.H3, h6: 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 japan as follows: it was reported that this was a percutaneous vertebroplasty (l1) for an osteoporotic vertebral fracture on (b)(6), 2023.In the surgery, the surgeon attempted to dilate the balloon in question to its optimal size and then apply negative pressure to remove it from the working sleeve.However, only the balloon could not be removed, and despite repeated dilatation negative pressure, the balloon could not be removed.The surgeon removed the stuck balloon and the working sleeve together.The balloon tip was cut and the working sleeve was re-installed.The surgery was completed successfully within 30 minutes¿ surgical delay.The patient outcome was reported to be stable.This report involves one synflate balloon/large- sterile.This is report 1 of 1 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H3, h6: the subject device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this 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.

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.H3, h6: part: 03.804.701s.Synthes lot: 82283823.Supplier lot: 82283823.Release to warehouse date: 19 july 2023.Supplier: (b)(4).No nonconformance reports (ncrs) 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.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the synflate balloon/medium- sterile had signs breakage along the base of the balloon.The allegation can be confirmed.A dimensional inspection and a functional test for the synflate balloon/medium- sterile were unable to be performed due to post manufacturing damage.Since the device was returned deflated and damaged, the complaint condition of not being able to inflate/deflate was not able to be replicated.Previous complaints were reviewed with the supplier and it was confirmed that all parts pass a 100% leak test and all lots have a sample burst test performed as part of lot acceptance.As part of the investigation, the supplier also performed a burst test on 2 new production devices and both burst above the required atmospheres.A visual examination of the burst test samples confirmed the condition of the balloons were consistent with the complaint devices.The synflate vertebral balloon surgical technique was reviewed; states to stop balloon expansion if any of the following happens: the desired outcome is reached.The pressure reaches 30 atm (440 psi).The maximum balloon volume is achieved.4.0 ml for the small balloon.5.0 ml for the medium balloon.6.0 ml for the large balloon.Any part of the inflated balloon length touches the cortical bone.The surgical technique guide also contains the following precautions: the balloons may leak if they are filled beyond their maximum volume or pressure.The performance of the balloons catheter may be adversely affected if it comes into contact with bone splinters, bone cement and/or surgical instruments.The surgical technique guide also recommends the following: to proceed with inflation slowly, stopping every few seconds to allow the bone to adjust to the pressure/volume changes.For bilateral procedures, inflate each balloon alternately in increments as part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the synflate balloon/medium- sterile would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Drawing/specifications reviewed the following drawings reflecting the current and manufactured revisions were reviewed: synflate catheter assembly depuy synthes.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: 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: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18318032
• MDR Text Key: 330946202
• Report Number: 8030965-2023-15634
• Device Sequence Number: 1
• Product Code: NDN
• UDI-Device Identifier: 07611819525399
• UDI-Public: (01)07611819525399
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.804.701S
• Device Lot Number: 82283823
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1