Occupation: synthes employee.Without a lot number the device history records review could not be completed.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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.B1, b5, h1: the initial complaint was reviewed and found not reportable.(add the rationale from the determination as to why this is now non-reportable.) complaint (b)(4).Is confirmed to be a duplicate of (b)(4).(b)(4) will be closed as a non-product issue (npi).This was created under the incorrect opco.It has been confirmed with engineering that the device has a missing screw not a broken screw.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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