Additional narrative: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Phone number: (b)(6).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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d9.Date device returned to manufacturer.H6 - codes updated to imdrf codes.Visual inspection: the depth gauge for 2.0mm and 2.4mm screws was received at cq.Upon visual inspection, it was observed that the needle component of the device was deformed/bent and not broken as reported.Rest of the surface of the device shows normal wear consistent with the device use which would not contribute to the complaint condition.Dimensional inspection: dimensional analysis was not performed due to the post-manufacturing damage.Documentation/ specification review: no design issues or discrepancies were found during this investigation.Investigation conclusion: the overall complaint was confirmed for the returned device as the tip was observed to be bent/deformed.However, the reported complaint condition of the device being broken cannot be confirmed as no signs of any breakages were observed.No definitive root cause could be determined based on the provided information.The unintended external forces might have contributed to the reported complaint condition.No new, unique or different patient harms were identified as a result of this evaluation.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 history lot - part # 319.006.Synthes lot # h521670.Supplier lot # h521670.Release to warehouse date: 01 oct 2018.Supplier: (b)(4).No ncr's were generated during production.Device history review - review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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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