The device was received, and the product evaluation is in progress.No conclusion can be drawn.Additionally, device history records review has been requested.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.Device history records review was completed for part: 309.039, lot: 9914904.Manufacturing location: (b)(4), release to warehouse date: jun 17, 2016.The device history record shows this lot was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all hardness, dimensional and visual criteria at the time of release with no issues documented during the manufacturing process.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Product investigation was completed.Visual inspection: the extraction bolt was received at with a piece of the cannulated screw stuck in the extraction bolt.Functional test: there is a broken piece of a cannulated screw that is stuck in the extraction bolt.The screw cannot be removed.The complaint was not able to be replicated.However, the complaint is confirmed for having a piece of the cannulated screw stuck within the extraction bolt.Dimensional inspection: dimensional analysis was not performed as relevant features are blocked and not able to be measured since there is a screw stuck in the extraction portion of the extraction bolt.Relevant drawings were reviewed.Conclusion: the complaint condition is confirmed as the extraction bolt was received with a piece of the screw stuck in the extraction bolt.There is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined it is possible that the device encountered unintended forces.No new malfunctions were observed during the course of this investigation.Based on the investigation findings, it has been determined that no corrective and/or preventative 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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