Model Number N/A |
Device Problem
Device Inoperable (1663)
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Patient Problems
No Information (3190); No Code Available (3191)
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Event Date 07/08/2016 |
Event Type
Injury
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Manufacturer Narrative
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Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.Report four of four for the same event; see also 0002184052-2016-00150, 00151 and 00152.
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Event Description
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The sales associate reported non-functional instruments.During a case the sleeves were unable to be used during the nxt case.It was reported that the sleeves have started to splay at the bottom, not allowing the screws to sit in the grooves correctly, therefore not letting the screwdrivers to be seated in the screw head.The surgery was completed using the short sleeves and pins.The doctor had to change technique from true percutaneous, because the short sleeves were not long enough for the obese patient, to a mini open type approach.
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Manufacturer Narrative
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The returned device was evaluated.There were no discrepancies found and the device performed as expected during a functional evaluation.The complaint cannot be confirmed.A review of the manufacturing records did not identify any issues which would have contributed to this event.
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Manufacturer Narrative
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Corrections to all fields.Further review of this report found that the event was incorrectly characterized.This event did not cause or contribute to any patient injury, and would not likely lead to a death or serious injury if this event type were to recur.
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Search Alerts/Recalls
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