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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: e1: (b)(6) hospital.E3: reporter is a j&j sales representative.G4: device is not distributed in the united states but is similar to device marketed in the usa.H3, h4, h6 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 med had signs of breakage and tearing off at the balloon, the distal tip of the balloon is heavily deformed, this conditions were most likely created during insertion process.The stent component was not returned.A dimensional inspection for the vbs w/balloon med was unable to be performed due to post manufacturing damage.The complaint was 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 30 atmospheres.A visual examination of the burst test samples confirmed the condition of the balloons were consistent with the complaint devices.The vertebral body stent surgical technique guide se_818940 rev.Ab was reviewed; it states to stop balloon expansion if any of the following happens: 1.Desired vertebral body height or angle is reached.The maximum stent diameter is 15 mm for vbb small and 17 mm for both vbb medium and vbb large.2.Pressure reaches 30 atm (440 psi).3.Vbs volume reaches maximum.4.0 ml for vbb small.4.5 ml for vbb medium.5.0 ml for vbb large.The surgical technique guide also contains the following warning: do not fill the balloons over their maximum volume or pressure.If this is done, they may leak.Vbs maximum volumes differ from vbb maximum volumes.The failures observed on the returned devices are consistent with failure due to over expansion or pressurization.The event description notes that the balloons reached the maximum guaranteed dilatation capacity and would not expand further and the pressure at rupture was 20 atm.This indicates that pressure was still being applied when the devices had already reached the maximum volume.Per the surgical technique guide, expansion should be discontinued as the maximum volume had been reached.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 thevbs w/balloon med would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition.The cause of the observed condition is likely due to continuing to pressurize the balloon after the maximum volume had been reached.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 vbs catheter assembly, depuy synthes, ndc-02-120987, rev.D current and manufactured.Dimensional inspection: n/a h4, h6 part: 09.804.601s.Lot: 82265424.Release to warehouse date: 01 nov 2022.Manufacturing site: synthes usa hq, inc.Expiration date: 01 nov 2025.Supplier: werk selzach.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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.
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Device report from synthes reports an event in japan as follows: it was reported that this was a vbs for ovf on july 20, 2023.After inflation of the balloons, they were deflated and removed.It was confirmed that contrast agents were remained in the cavities inside the vertebral bodies by an image intensifier.There were no problems with the balloons in inflation or use, but the balloons are probably damaged.The sales rep could not confirm whether the balloons had pinholes.The surgery was completed successfully with no surgical delay.Patient status/ outcome: stable.No further information is available.This report is for one (1) vbs w/balloon med.This is report 1 of 2 for complaint (b)(4).
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