|
Catalog Number 09.804.600S |
Device Problem
Material Integrity Problem (2978)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 09/13/2022 |
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.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.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 a centrum fracture on (b)(6) 2022.While inflating up the left and right trial balloons, it appeared that contrast medium had leaked into the right balloon in question.Since blood was aspirated, the surgeon determined that the balloon in question was broken.The balloon was broken when the surgeon injected 2cc of contrast medium.The surgeon used a new balloon, and the surgery was completed successfully without any surgical 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.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.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.
|
|
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: h3, h4, h6: part # 09.804.600s.Synthes lot # j001643.Supplier lot # j001643.Release to warehouse date:09 oct 2020.Supplier: confluent medical technologies.No ncrs were generated during production.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 heavy tearing off at the distal section of the balloon.The stiffening wire component was not returned.A dimensional inspection for the vbs w/balloon sm 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 was reviewed; it states to stop balloon expansion if any of the following happens: 1.Desired vertebral body height or angle is reached.2.Pressure reaches 30 atm (440 psi).3.Vbs volume reaches maximum limit.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 failure observed on the returned device is consistent with failure due to over expansion or pressurization.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 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.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.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.
|
|
Search Alerts/Recalls
|
|
|