Reporter is a j&j employee.Investigation summary: visual inspection: the 10 nm torque limiting wrench for 12 point nut (p/n: 388.266, lot #: 4271208) was returned and received at us cq.Upon visual inspection, no issues were identified with the returned device.Functional test: a functional test was performed at service and repair evaluation.The low torque of the device was measured to be 9.95 nm.This is not within the specification of 10 nm -11 nm per (b)(4).Service and repair evaluation: during evaluation at service and repair, the 10nm torque limiting wrench for 12-point nut was found to have failed calibration.The repair technician reported that there is adhesive residue on tip of chuck, unable to remove.Torque test low is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is unknown.The item will be forwarded to customer quality.The evaluation was confirmed.Document/specification review based on the date of manufacture, the current and manufactured revision of drawings were reviewed: loaner set product-specific inspection and verification instructions, 10 n.M torque wrench.Complaint confirmed? yes, the device received failed low in calibration.Hence confirming the allegation.Investigation conclusion the complaint condition was confirmed for the 10 nm torque limiting wrench for 12 point nut (p/n: 388.266, lot #: 4271208).There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause could be due to device maintenance.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot: part number: 388.266, synthes lot number: 4271208, supplier lot number: n/a, release to warehouse date: may 10, 2001, expiration date: n/a, supplier: (b)(4).No ncrs were generated during production.Device history review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.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 10nm torque limiting wrench for 12-point nut was found to have failed calibration.There was no patient involvement.This report is for one (1) 10nm torque limiting wrench for 12-point nut.This is report 1 of 1 for (b)(4).
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