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Model Number 283913000 |
Device Problem
Chemical Problem (2893)
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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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Additional narrative: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a j&j sales representative.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 (b)(6) 2021, the pump stopped at 3-4cc when the bone cement was applied halfway through and could not be advanced.The original instructions were followed.It is suspected whether this batch number is defective.There was no patient consequences reported.No further information provided.This report is for one (1) confidence spinal cement system confidence kit spinal cement system 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 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.H4.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.H10 additional narrative: h3, h4, h6- the complaint condition was confirmed for the confidence kit, no needles, (p/n: 283910000, lot #: 288078).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 no indication that a design or manufacturing issue has caused the issue and hence the root cause cannot be determined.The possible cause could be the cement that 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.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.Cement retest results were checked, and no concerns were observed with the testing results.Please refer to that attached investigation and retest results for complete retest results performed on the cement lot number.Device history lot = > the dhr of product code: 283913000.Lot : 288078.Was electronically reviewed and no non-conformances.Were observed during the manufacturing process.The product was released on: 09.09.2020.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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