Product complaint # (b)(4).Reporter is a j&j sales representative.Investigation summary: it was reported that on (b)(6) 2022, the depth gauge was found unable to slide to take apart.There were no patient consequences.Procedure outcome was unknown.This complaint involves one (1) device.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 depth gauge for 2.0mm and 2.4mm screws it was observed that the needle component of the device was bent.Rest of the surface of the device shows normal wear consistent with the device use which would not contribute to the complaint condition.A dimensional inspection for the depth gauge for 2.0mm and 2.4mm screws was unable to be performed due to post manufacturing damage.A functional test was performed and the needle component did not slide smoothly inside the body component of the device due to bent condition.The complaint condition was able to be replicated.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 2.0mm and 2.4mm screws 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.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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