Model Number N/A |
Device Problem
Separation Failure (2547)
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Patient Problem
No Information (3190)
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Event Date 03/04/2016 |
Event Type
Injury
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Manufacturer Narrative
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Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.This report is number 1 of 2 mdrs filed for the same event (reference 1825034-2016-01104 / 01105).
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Event Description
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It was reported a patient underwent a right femoral fixation procedure on (b)(6) 2016.During the procedure, the first distal screw fractured off.The remaining part of the screw was removed from the patient.During removal of the plate, one of the three lag screws previously implanted cold-welded to the plate.The plate and screws were removed from the patient.Another plate and screws were used to complete the procedure.This resulted in a delay of approximately 30 minutes.
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Manufacturer Narrative
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This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.(b)(4).Examination of returned device found no evidence of product non-conformance.Review of the device confirmed the reported condition.Root cause of the event was most likely attributed to cold-welding or galling of the screw threads.
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Search Alerts/Recalls
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