Catalog Number 284176 |
Device Problem
Unknown (for use when the device problem is not known) (2204)
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Patient Problem
Surgical procedure, delayed (2565)
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Event Date 04/05/2015 |
Event Type
Injury
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Event Description
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The equipment malfunction during the procedure.Resume of surgery after the alternative was arranged.Procedure was extended 120 minutes.The surgery was completed with the competitors device.Associated medwatch #: 1221934-2015-00737, 1221934-2015-00739, 1221934-2015-00740.
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Manufacturer Narrative
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Attempts have been made to retrieve additional information about the event and device.The additional information will reportedly be forwarded to depuy mitek however it is not known if it will be received within the 30 day reporting requirement, therefore depuy mitek would like to file this initial medwatch report at this time.When and if additional information is received it will be reflected in a follow-up medwatch report.Awaiting return.
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Manufacturer Narrative
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The complaint device has not been returned, despite requesting for it several times, therefore unavailable for a physical evaluation.Further, a review into the depuy synthes mitek complaints system revealed no other complaints for this lot of devices that were released to distribution.We cannot discern a root cause for the reported failure mode.At this point in time, no corrective action is required and no further action is warranted.This file will remain receptive to any potential forthcoming information received that is pertinent and germane to this issue.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.
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Event Description
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The equipment malfunction during the procedure.Resume of surgery after the alternative was arranged.Procedure was extended 120 minutes.Additional information: the surgery was completed with the competitors device.Associated medwatch #: 1221934-2015-00737, 1221934-2015-00739, 1221934-2015-00740.
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Search Alerts/Recalls
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