Reporter is a synthes employee.Part #: 319.090.Lot #: l731175.Manufacturing site: (b)(4).Release to warehouse date: 14 feb 2018.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Customer quality investigation: the device was not returned.A photo-investigation was performed on the images.Upon inspecting the images provided, it was observed the needle component of the device was slightly bent.A functional assessment was not able to perform since the device was not returned.The complaint could not be confirmed for the reported condition, unable to assemble.However, the overall complaint could be confirmed for the bent condition.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.Conclusion: the overall complaint can be confirmed during photo investigation.During the investigation, no product design issues, or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive 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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Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2021 that the sizer would not grip the cortex to measure and the stardrive was too worn to grip the screw.Concomitant device reported: unk - screw (part#: unknown, lot#: unknown, quantity: 1).This report is for (1) depth gauge for small screws.This is report 1 of 2 for (b)(4).
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