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Catalog Number SD800.402 |
Device Problem
Defective Device (2588)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/23/2023 |
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.Reporter is a j&j employee.Complainant part is not expected to be returned for manufacturer review/investigation.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 depuy synthes reports an event in (b)(6) as follows: it was reported that on (b)(6), 2023 the customer reported the size of implant was planned too large, so the result was not satisfactory and had to be replaced.This report is for one (1) psi sd800.402 peek implant.This is report 1 of 1 for complaint pc 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.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.Product code: sd800.402.Lot number: 4415p57 (me23-emo-kul).Manufacturing date: 02-feb- 2023.Manufacturing site: jabil mezzovico.No ncr's generated during production.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.The product was not returned to depuy synthes for evaluation.The r&d team conducted and investigation based off the case records and complaint documentation.Per the complaint description above, the psi case files and communication were reviewed.The investigation included an end-to-end process review of the documentation and forms along with the surgeon complaint report and the received details on the case.No images intra or post operatively were received with the complaint.The implant design was completed and verified as per the depuy synthes design instructions and roles.After the surgeon reviewed the design and approved it with his signature, the device was produced and inspected according to process and released upon acceptable quality inspection.As per the communication stated from the surgeon above.The originally planned and designed device was reviewed and approved by the surgeon.However, post-operatively the cosmetic outcome was deemed not satisfactory, because the initial device was implanted and revision surgery was required, this case falls under the complaint process.Based on the information and documents available, this design investigation for the initial device is closed as not valid regarding a design related root cause.As a part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed for the psi 60*20*40 peek.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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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