Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a synthes employee.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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It was reported that on an unknown date, the handle with quick coupling, small was broken.It is unknown how the issue was discovered.There is no patient consequence.This report is for one (1) handle with quick coupling, small.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, h6: part # 311.43, synthes lot # 5220670, supplier lot # na, release to warehouse date: april 24, 2006, manufactured by synthes brandywine, no ncr's were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Visual inspection: upon visual inspection nothing is broken instead the end cap component (which is press fit onto the handle during manufacturing) was observed to fall apart.No other visual issues were identified with the returned components of the device.Functional test: a functional test was performed by press fitting the end cap to the handle component, and it could attach however it can easily be pulled off from the handle, thus, conforming the complaint.Additionally, the tap holder assembly is slightly sticking which may hinder the functionality of the device.Dimensional inspection: dimensional inspection was not performed due to post manufacturing damage.Document/specification review: tap handle for small taps and csk tap handle endcap tap handle tap holder assembly based on the review of the above drawings, no design issues contributing to relevant complaint condition were identified.Investigation conclusion: the complaint condition for the instrument was confirmed as the endcap component fell apart and the assembly was sticking.No definitive root-cause can be determined based on the provided information.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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