Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes 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, the end of one of the tongs on the lobster claw broke off and one of the points to points was bent.No fragments were generated.There was no surgical delay.The procedure was successfully completed.There was n o patient consequence.Concomitant devices reported: reduction forceps with points broad-ratchet (part number 398.41, lot unknown, quantity 1).This report involves one (1) reduction forceps with serrated jaw-ratchet 144mm.This is report 1 of 1 for (b)(4).
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