Product complaint # (b)(4).The investigation could not be completed; no conclusion could be drawn at the time of filing this report.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.A review of the device history record has been requested.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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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.Shipped back device ¿synframe-extension f/387.336+387.337¿ 387.338 with lot number 4l53724 is in proper conditions.In the involved device instead they are positioned in reverse: component 2 (50131167) is below component 3 (50131152).Functional tests were performed on ¿synframe-extension f/387.336+387.337¿ 387.338 with lot number 4l53724 the following functional test was performed: the screw must move freely.The device passed the test performed.The complaint condition is confirmed, in fact, being wrongly assembled the device cannot be connected to the synframe ring.Device history lot part: 387.338, lot: 4l53724, manufacturing site: haegendorf, release to warehouse date: 19.June 2019.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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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