Product complaint #: (b)(4).Additional narrative: reporter is a j&j employee.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the depth gauge for 2.0 and 2.4 screws-70 was found to have the needle broken, fragment is included in the evidence.Protection sleeve is missing.A dimensional inspection for the depth gauge for 2.0 and 2.4 screws-70 was unable to be performed due to post manufacturing investigation.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the depth gauge for 2.0 and 2.4 screws-70 would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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.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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Device report from synthes reports an event in the usa as follows: it was reported that on unknown date, during a set audit, one (1) depth gauge for 2.0 and 2.4 screws-70 was found broken after the set was washed in sterile processing department (spd).No patient consequences.This complaint involves one (1) device depth gauge for 2.0 and 2.4 screws-70.This is report 1 of 1 for complaint (b)(4).
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