Reporter is a j&j employee.Service and repair history: the previous service event for part number 03.641.004 with lot number(s) h430307-11 has been reviewed.The customer called in a service request for this item on 20-oct-2020 for failed calibration.The item was previously returned for service on 16-jan-2020 due to out of specification.The previous service condition of out of specification is relevant to the current complained issue of failed calibration.The manufacture date of this item is 12-feb-2018.The service history review is confirmed.A product investigation was conducted.Service and repair evaluation: during evaluation at service and repair, the socket wrench for veptr nut was found to have failed calibration.The repair technician reported the device failed calibration and required further testing at the vendor.The cause of the issue is failed high.The item will be repaired and will be returned to the customer upon completion of the service and repair process.The evaluation was confirmed.The device was deemed serviceable and will be returned to the customer, no design or manufacturing issues were identified therefore it has been determined that no corrective and/or preventative action is proposed.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 on (b)(6) 2020, during evaluation at service and repair, the socket wrench for veptr nut was found to have failed calibration.There was no patient involvement.This report is for one (1) socket wrench for veptr nut.This is report 1 of 1 for complaint (b)(4).
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