Reporter is synthes sales consultant.The device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 on an unknown date, the 5.0mm flexible shaft could no longer be connected to an unknown driver.It is unknown how the issue was discovered.It is unknown if there were patient and surgical involvement.Concomitant device reported: driver (part # 351.140, lot # unknown, quantity unknown) this complaint involves one (1) device.This is report 1 of 1 for complaint (b)(4).
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Product complaint # (b)(4).Background: 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.H10 additional narrative: h3, h4, h6: a review of the device history record.Device history lot : part: 352.040, lot: 2260145, manufacturing site: bettlach, release to warehouse date: 03.May 2007.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Device history batch null, device history review 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.It was reported on an unknown date, the 5.0mm flexible shaft could no longer be connected to an unknown driver.It is unknown how the issue was discovered.It is unknown if there were patient and surgical involvement.Concomitant device reported: driver (part # 351.140, lot # unknown, quantity unknown) this complaint involves one (1) device.Investigation flow: device interaction / functional.Visual inspection: the 5.0mm flexible shaft (part # 352.040 / lot # 2260145) was received at us cq, no mating devices were returned.Upon magnification of the distal coupling it was identified that there were transverse stress marks along the individual prongs.The distal coupling was bent inward.There was no damage identified on the proximal coupling that would inhibit functionality.There were light scratches along the proximal coupling, the part number etch was eligible to due to the scratches.Functional test: functional testing was unable to be performed due to a lack of received mating devices.Can the complaint be replicated with the returned device(s)? since functional testing was unable to be performed, the complaint condition was unable to be replicated/tested.Non-conforming dimensions on the distal coupling can be attributed to the inwardly bent condition of the coupling.Document/specification review: conclusion: the overall complaint was confirmed for the received 5.0mm flexible shaft as its distal coupling was deformed such that its geometry was no longer conforming to its designed tolerances.This change in geometry would contribute to a device interaction issue.Although no definitive root-cause can be determined its possible the device experienced unintended forces leading to the observed bent condition.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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