MAUDE Adverse Event Report: SYNTHES GMBH VBS W/BALLOON SM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number 09.804.600S

Device Problem Material Integrity Problem (2978)

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

Event Date 01/20/2023

Event Type  malfunction  

Event Description

Device report from synthes reports an event in japan as follows: it was reported that on (b)(6) 2023, the patient underwent percutaneous vertebroplasty for a lumbar vertebral compression fracture.The balloon was inflated up as per procedure while checking the image.Although the maximum inflated volume was 4.5 ml, the balloon was over-inflated up to 5.0 ml.When the balloon was removed, the inflation system showed a decrease in pressure before applying negative pressure.The balloon was deflated, and it was removed.When the balloon was inflated up again, contrast leakage was confirmed.The surgery was completed successfully with a 30-minute delay.No further information is available.This report involves one vbs w/balloon sm.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.Additional narrative: device available for evaluation: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Initial reporter occupation: reporter is a j&j employee.Pma/510k: device is not distributed in the united states, but is similar to device marketed in the usa.Without a lot number the device history records review could not be completed.Product was not returned.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.

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 information is obtained that was not available for this 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: a manufacturing related potential cause was not suspected, therefore, per franchise complaint product investigation procedure, no manufacturing record evaluation is required.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 vbs w/balloon sm had signs of breakage gaps at the distal tip of the balloon.Additionally, the proximal end of the shaft presented light signs of tearing, leakage could happened through this section too.The stent was not returned along with the device.The vertebral body stent surgical technique guide was reviewed.Following relevant statements were found.Warnings: do not inflate the balloons beyond their maximum volume or pressure.If this is done, they may leak.Vbs maximum volumes differ from vbb maximum volumes.In case of contrast medium leakage, pull vacuum, insert stiffening wire and remove balloon.Do not reuse the balloon.Precautions: the vbs expansion pressure and volume on the inflation system must be monitored carefully on the inflation system¿s phosphorescent manometer (units: bar/atm, psi) and syringe body with black volume markers (units: ml/cc), respectively.With the available information and review of the surgical technique, the breakage condition of the balloon and leakage of the saline solution can be traced to unintended use error since the balloon was inflated beyond its maximum volume capacity and re-inflated, contrary to the instructions for use and indications.A dimensional inspection for the vbs w/balloon sm was unable to be performed due to post manufacturing damage.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 vbs w/balloon sm 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 were reviewed: vbs catheter assembly depuy synthes (current).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.H10 additional narrative: d9.Date device returned to manufacturer.H3.Device evaluation.H3, h6: the device was 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.

• Brand Name: VBS W/BALLOON SM
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• 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: 16363230
• MDR Text Key: 309403230
• Report Number: 8030965-2023-01732
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 07611819471849
• UDI-Public: (01)07611819471849
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 09.804.600S
• Device Lot Number: 82236539
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1