Model Number NAIL RIGHT A6° D10 L180 |
Device Problem
Failure to Eject (4010)
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Patient Problem
No Information (3190)
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Event Date 01/16/2019 |
Event Type
malfunction
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Manufacturer Narrative
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This is the final report submitted regarding this surgical event and medical device.
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Event Description
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During a surgery in order to remove a nail at the ankle, the surgeon notices that one of the screws locking the nail seems "welded".The surgeon was unable to perform the planned operation and had to perform a tibia osteotomy requiring an additional surgical approach as well as an increased duration of operation.
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Manufacturer Narrative
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This is the final report submitted regarding this surgical event and medical device.The information contained in this report is being provided to the fda to comply with regulations regarding medical device reporting and is based on information submitted by others that may or may not be factually correct.This submission does not constitute a determination or admission that a device has malfunction or is related to a death or injury.
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Search Alerts/Recalls
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