Device report from depuy synthes reports an event in (b)(6) as follows: it was reported by the customer in (b)(6) that during a spinal procedure on (b)(6) 2022 using the orthopaedic cement device kit, it was observed that some sterile water leaked from the hydraulic pump connection despite the fact that the cement was correctly mixed in the initial phase.According to the report, the event occurred during the injection in the final phase of the surgical procedure.There was a delay of 10 minutes.There were no adverse patient consequences reported.No additional information was provided.This report is for one (1) device.
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Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and 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 history lot: a manufacturing record evaluation was performed on product code: 283907000 with lot number: 326213; and no non-conformances / manufacturing irregularities were identified during the manufacturing process.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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