Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j employee.Without a lot number the device history records review could not be completed.Product was not returned.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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It was reported that on (b)(6) 2020 during an unknown procedure, the connecting screw broke off inside the lag screw.There was a surgical delay of 15 minutes.The procedure was successfully completed.Concomitant devices reported: unknown lag screw (part# unknown, lot# unknown, quantity# unknown).This report is for 1 dhs®/dcs® coupling screw.This is report 1 of 1 for (b)(4).
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