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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.D9: complainant part is not expected to be returned for manufacturer review/investigation.G4: device is not distributed in the united states, but is similar to device marketed in the usa.H3, h4, h6: device history record (dhr) review conducted: part # 07.702.016s.Lot # 2j53541.Manufacturing site: werk selzach logistik.Release to warehouse date : 29.Sep.2022.Expiration date: 01.Sep.2025.Supplier: (b)(4).A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.H3, h6: 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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Device report from depuy synthes reports an event in china as follows: it was reported that during the surgery on october 30, 2023, the handle could not be pushed.The cement was prepared by pouring the liquid into the powder bucket according to the operating procedure.The storage temperature of the cement prior to usage was operating room environment.Another device was used to complete the surgery.There were no adverse consequences to the patient.The surgery was successfully completed.There was no surgical delay.No additional information could be provided.This report is for one (1) vertecem v+ cement kit.This is report 1 of 1 for (b)(4).
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