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 open reduction internal fixation (orif) femur procedure, the 2 depth gauge broke, 2 ratcheting screwdriver handle and 2 cannulated screwdriver handle with ratchet quick coupling had stopped ratcheting, 1 double drill sleeve had broken off soft tissue guide, and 2 stardrive screwdriver shaft had stripped head.The procedure was successfully completed using another set.There was a 5 minutes surgical delay.There was no patient consequence.This report is for 1 2.0/2.4mm depth gauge 50mm.This is report 6 of 6 for (b)(4).
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