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Device Problem
Device-Device Incompatibility (2919)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/17/2020 |
Event Type
malfunction
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Manufacturer Narrative
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This report is for an unknown plates: va-lcp distal humerus plates/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.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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Event Description
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Device report from (b)(6) reports an event as follows: it was reported that patient underwent an open reduction internal fixation (orif) procedure for distal humerus on (b)(6) 2020.After completing the posterolateral plate placement, when the screw was inserted to the distal hole of the inner plate, the screw spun without fastening and was not locked.The surgeon tried to reinsert the screw, but the screw was idling and could not be removed.The screw head was buried in the screw hole of the plate, and it was difficult to remove the screw.The surgeon judged that the screw would not come out even if it was left in this way, so the screw was left as it was.The surgery was completed with a thirty minute delay.No further information is available.This report is for one (1) plates: va-lcp distal humerus plates.This is report 2 of 3 for (b)(4).
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Manufacturer Narrative
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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.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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Search Alerts/Recalls
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