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Model Number 283910000 |
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 01/13/2022 |
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: 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 taiwan as follows: it was reported that the bone cement was soaked according to the original factory procedure, and the connecting pipe leaked when the injection was started.There was no surgical delay.The procedure was successfully completed.There was no patient outcome/consequences.This report is for one (1) confidence spinal cmt sys, 11c.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: d9: device returned.H4: manufacture date added.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 there was hardened cement inside the cement reservoir.No evidence of cement leak was found on the surface of the reservoir.The pump body was filled with water.No significant product problem was found on any component of the confidence spinal cmt sys, 11c, p/n: 283910000.A dimensional inspection was not performed as it is not applicable to the complaint condition.A functional test to assess the the reported allegation was conducted.The pump was turned clockwise and the plunger was moved down.No evidence of water leak was observed.The complaint condition was not replicated.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed as the confidence spinal cmt sys, 11c was found to have no damage or defects.No definitive root cause could be determined.There was no indication that a design or manufacturing issue contributed to the complaint.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: a manufacturing record evaluation was performed for the finished device.Product code: 283910000.Lot number: 353623.It was electronically reviewed, and no non-conformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 08/09/2022.Qty: 48.Cement number: product code : 183901001 / batch number : 3795924.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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