Model Number N/A |
Device Problem
Difficult to Remove (1528)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/22/2016 |
Event Type
malfunction
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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.
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Event Description
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It was reported when the surgeon attempted to unlock the extender sleeve to remove it from the screw, the screwdriver did not fit into the head of the screw.The screwdriver was able to loosen the locking nut on the sleeve, however it didn't completely seat down into the locking nut.The extender sleeve was removed and the surgery was completed successfully with no delay or injury.
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Manufacturer Narrative
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The returned sleeve was evaluated.Deformation was found which prevented the driver from fitting when assembly was attempted.The complaint is confirmed.Since the reporter stated that the issue was discovered while trying to unlock the extender sleeve, it is likely that the deformation occurred at or following the initial locking of the device.A review of the manufacturing records did not identify any issues which would have contributed to this event.
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Search Alerts/Recalls
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