| Catalog Number 09.804.601S |
| Device Problems
Inflation Problem (1310); Material Integrity Problem (2978)
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| Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 02/01/2023 |
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Event Type
malfunction
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Manufacturer Narrative
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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.Additional narrative: initial reporter occupation: reporter is a j&j employee.Device available for evaluation: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.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.
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Event Description
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Device report from synthes reports an event in japan as follows: it was reported that this was a percutaneous vertebroplasty (l1) for the osteoporosis compression fracture on february 1, 2023.The event took place in sequence as follows: after creating hole as per procedures, the appropriate size was selected, and a trial balloon was performed.Then, the stent balloon was inserted bilaterally.Inflation to 4.5 ml bilaterally did not cause any problems.However, when the balloon was inflated up to 5.0 ml bilaterally, a pressure dropped in the inflation system on the left side of the vertebral body.Therefore, the balloon was immediately deflated, and aspiration was started on the same side.Saline solution was poured to wash and aspirate the remaining contrast agent in the vertebral body.The images showed that there was no residual contrast material.The balloon was well inflated bilaterally, and the procedure was completed without any additional procedures.The surgery was completed successfully within 30 minutes delay.When inflation and deflation of the balloon in question was performed outside the body, air leakage and balloon damage were confirmed.When the balloon was inflated up to 5.0 m, the pressure was approximately 16 atm.The rate of inflation was performed at a leisurely pace, and excessively stress was not on the device.The surgeon requested an investigation to confirm the damaged part of the balloon and to find out the possible cause of the damage as a countermeasure.No further information is available.This report is for one (1) vbs w/balloon med.This is report 1 of 1 for complaint (b)(4).
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Manufacturer Narrative
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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 information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.
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Manufacturer Narrative
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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: h3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.
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Manufacturer Narrative
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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.H10 additional narrative: h3: manufacture date added.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 presents signs of tearing-off along the surface of the balloon, and the distal tip is deformed.These conditions are most likely due to insertion process of the device.The protection sleeve was not returned.A dimensional inspection for the device was unable to be performed due to post manufacturing damage.A functional test cannot be performed as the device was received damaged and in deflated condition.However, inability to inflate or deflate can be attributed to the breakage of the balloon.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 device.The vertebral body stent surgical technique guide 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.Simultaneous dilatation of bilateral devices is essential for optimal device performance.Once stent expansion has begun the stent cannot be undeployed or repositioned.The system has been validated by simultaneously implanting two stents to ensure optimal intraoperative load capacities.Vbs maximum volumes differ from vbb maximum volumes.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.The efficacy of the balloon catheter may be adversely affected if it comes into contact with bone splinters, bone cement, and/or surgical instruments.The event description indicates that the balloon was inflated and then started to lose pressure.The pressure and/or volume achieved prior to failure of the device was reported to be 5.0ml and 16atm, which is within the surgical technique specification.However, the observed condition of the balloon is consistent with over expansion or pressurization.It is also possible that the tip was damaged due to contact with the bone once it was fully inflated.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 with balloon, medium 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.Device history lot: part # 09.804.601s.Synthes lot # 82253190.Supplier lot # 82253190.Release to warehouse date: june 03, 2022.Supplier: (b)(4).No ncrs 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.E2, e3: initial reporter is a health professional.
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