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Model Number 283913000 |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.
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Event Description
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Device report from synthes reports an event in (b)(6) as follows: it was reported that during a procedure on an unknown date in 2021, there was a leak of fluid from the pump.The procedure was successfully completed with the use of another product of the same type.No consequences for the patient reported.This report is for one (1) confidence kit, no needles.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.H3, h4, h6- product was not returned.Based on the information available, it has been determined that no corrective and 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 history lot: the dhr of product code: 283913000.Lot : 298991.Was electronically reviewed and no non-conformances were observed during the manufacturing process.The product was released on: 14.01.2021 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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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.H3, h6: visual inspection: the confidence kit, no needles was returned and received at us customer quality (cq).Upon visual inspection, only the confidence pump assembly and the cement reservoir was returned from the kit.The cement was hardened inside the cement reservoir and there was sterile water inside the pump.No other issues were identified with the returned device that could impact the device functionality.Functional test: a complete functional test could not be performed due to the solidified cement.However, when the handle was twisted to transfer the sterilized water through the connector, the sterilized water was being transferred to the proximal side of the confidence pump body above the piston tapered nut.The connector component was functioning as intended but no sterilized water was able to pass through the connector due to this internal leakage.Dimensional inspection: a dimensional inspection was not performed as the internal components of the pump and the connector were inaccessible without destruction of the device.Document/specification review: the following current and manufactured revision of drawings were reviewed: confidence, final packaging assembly; confidence pump assembly; confidence pump body assembly; confidence pump piston assembly; investigation conclusion: the complaint condition was confirmed for the confidence kit, no needles.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.There is a possibility the cement may have solidified prematurely due to the manner with which it was stored and other environmental factors that might have an impact on the cement¿s setting time.The confidence spinal cement system kit¿s instructions for use states that the cement should be stored unopened in its original packaging, in a dry, clean place away from light, at a maximum temperature between 41° f (5° c) and 77° f (25° c).Working time at operating room and material temperature of 20 degrees celsius is 9 minutes.The handling characteristics and setting time can vary if the product has not been fully equilibrated at 68° f (20° c) before use.The unopened product should be stored at 68° f (20° c) for a minimum of 24 hours before use.No other potential defects were observed.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.
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Search Alerts/Recalls
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