Additional product code hwc.Reporter is jnj representative.The device was 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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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.Investigation selection investigation site: cq zuchwil, selected flow: packaging.Visual inspection: the screw was received with the reported condition that the inner tube did not disengage from outer tube.The inspection performed at cq zuchwil confirmed that after unscrewing the outer cap the entire inner tube (cap with holder and screw) is retained within the outer tube, preventing the screw from being removed and used.No further damage is visible.Summary: the complaint condition is confirmed as the inner tube is retained within the outer tube during disassembly preventing the screw from being removed and used.This production lot was manufactured in october 2019 according to the specification.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the inspection or release of the product that would contribute to this complaint condition.Further investigation has shown that this production lot is part of the corrective and preventive action (capa) and part of the field safety notice.The root cause was identified during the performed capa evaluation (inadequately defined design of the inner tube & inner cap).All further investigations and actions will be documented within capa and hence the in the investigation flow listed remaining investigation steps are not required.Device history lot product code: 02.200.014ts, lot number: 6l28349, manufacturing site: selzach, supplier: (b)(4), release to warehouse date: oct.14, 2019, expiry date: sep.01, 2024.Lot 6l28349 is part of capa, therefore no investigation is required for this lot number as the investigation including root cause definition has already been performed under this capa.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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