The dhr of product code: 283913000.Lot : 294149.Was electronically reviewed and no non-conformances.Were observed during the manufacturing process.The product was released on: 30.11.2020.Qty: (b)(4).Visual inspection: the confidence kit, no needles (p/n: 283913000, lot #: 294149) was returned and received at us customer quality (cq).Upon inspection of the returned device, it was observed that only the mixer handle and the mixer bowl were returned and the entire kit was not returned.The components of the mixer handle fell apart and the residue of cement was observed to be hardened on the mixer handle and the mixer bowl.No other issues were identified with the returned device.Device failure/defect identified? yes.Functional test: an overall functional test could not be performed due to the solidified cement.However the components that fell apart could have caused the complaint condition.Can the complaint be replicated with the returned devices? yes.Document/specification review, confidence cement reservoir & mixer kit, confidence assembly, mixer handle, confidence, mixing well.Dimensional inspection: complaint relevant dimensional inspection could not be performed due to the solidified cement and the device geometry.Complaint confirmed? yes.Investigation conclusion the complaint condition could be confirmed for the returned device as the returned device was observed to have fell apart.There was no indication that a design or manufacturing issue has caused the issue 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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