Part: 414.838 lot: 122p030 manufacturing site: (b)(4) release to warehouse date: 21 april 2021.A manufacturing record evaluation was performed for the lot #122p030 of article # 414.838 and no non-conformances were identified.Photo investigation: the device was not returned for investigation.A photo investigation was completed on the image.Initial investigation had been completed by jabil- grenchen, the manufacturing site and a report was received.In one of the images, there is an empty packaging and a screw next to it.The event description states that the package and its content were separated.It is not clear from the image whether there is any damage to the package or sealing which could have caused the screw to come out of the sterile package.Hence, the package needs to be returned to evaluate whether this is a manufacturing issue or not.Manufacturing record evaluation revealed no non-conformance that could have contributed to this issue.Document/specification was not reviewed as they are not relevant to the complaint condition of packaging issues.Since the device was not returned, an as-received condition and dimensional inspection could not be reviewed.Conclusion: the complaint on the packaging can be confirmed, but a definitive assignable root cause was not identified from the available information.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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