Model Number N/A |
Device Problems
Disconnection (1171); Fracture (1260)
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Patient Problem
Bone Fracture(s) (1870)
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Event Date 03/27/2014 |
Event Type
Injury
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Event Description
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It was reported that patient underwent a fixed femoral fracture procedure on (b)(6) 2014.During the procedure, while the surgeon used the slap hammer, the targeting device disconnected from the nail.The nail was engaged several times with the same results.An additional connecting bolt was attempted for use with the same results.Surgeon completed the procedure manually.This caused a delay of greater than 30 minutes in the procedure.
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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.Product is being returned to manufacturer, but has not yet been received.Upon completion of evaluation, a follow up report will be sent to the fda.This report is number 1 of 2 mdrs filed for the same event (reference 1825034-2014-03129 / 03130).
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Manufacturer Narrative
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Evaluation of device revealed threads of the instrument were damaged.Evaluation of device suggests the instruments were likely damaged after initial distribution.Root cause for the reported event determined to be damage to the instruments.
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Search Alerts/Recalls
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