Reporter is a synthes employee.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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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It was reported that on an unknown date, during routine incoming inspection of a loaner set, it was observed that the depth gauge for 1.3mm and 1.5mm screws was bent.There was no known patient or hospital involvement.This report is for 1 depth gauge for 1.3mm and 1.5mm screws.This is report 1 of 1 for (b)(4).
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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: part 319.004, lot 4478682: release to warehouse date: october 07, 2002.Manufactured by synthes brandywine.No non-conformance reports (ncrs) were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.H3, h6: a product investigation was completed: upon visual inspection it was noticed that the needle component is bent.No other issues were identified with the device.Dimensional inspection showed the relevant dimensions were conforming.The relevant drawings were reviewed; no design issues or discrepancies were identified.This complaint is confirmed as the needle component is bent.No definitive root cause could be determined based on the provided information.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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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