It was reported that on an unknown date, patient underwent for an orthopedic surgical procedure.The augment was mixed according to instructions and cannula was prefilled with 4ml of augment and stopped when it started coming out.When the surgeon put the cannula into the sleeve into the helical blade to insert the augment, nothing would come out.The surgery was completed with a surgical delay of 7 minutes.There was no patient consequence reported.Concomitant device reported: unk - guides/sleeves/aiming: sleeve (part# unknown; lot# unknown; quantity: 1); unk - nail head elements: tfna helical blade (part# unknown; lot# unknown; quantity: 1); unk - insertion instrument (part# unknown; lot# unknown; quantity: 1).This complaint involves three(3) devices.This report is for (1) traumacem(tm) v+ syringe kit - sterile.This is report 2 of 2 for (b)(4).
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Product complaint #: (b)(4).Event year is reported as 2021; however exact date of event is unknown.Complainant part is not expected to be returned for manufacturer review/ investigation.Reporter is a j&j representative.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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 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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