The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h6: part: 03.130.250-us, lot: 9849893, manufacturing site: balsthal, release to warehouse date: 18 march 2016.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Visual inspection: the complaint device depth gauge for screw (product code: 03.130.250, lot number: 9849893) was returned to customer quality (cq) west chester for investigation.During visual inspection, the needle of the bent gauge was found bent and deformed.Device/defect identified: yes.Document /specification review: based on the date of manufacture, the current and manufactured version of the drawings were reviewed.Depth gauge for screws 1.3/1.5/2.0.Dimensional inspection: it is evident from visual inspection that device needle was bent, hence a dimensional inspection as deemed irrelevant.Complaint confirmed: complaint can be confirmed based on the available information.Conclusion: the depth gauge needle was found damaged during investigation, hence the complaint was not confirmed.A definitive root cause cannot be determined from the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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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