Device Problem
Sticking (1597)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/17/2015 |
Event Type
malfunction
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Manufacturer Narrative
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This report is for an unknown 95mm helical blade/unknown lot.Part and lot numbers are unknown; udi number is unknown.Device was not implanted/explanted.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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It was reported that while inserting a trochanteric fixation nail (tfn), the blade became stuck and could not be advanced or removed.A slap hammer and an extraction device were used to remove the trochanteric fixation nail causing a twenty (20) minute surgical delay.A second tfn nail set was used to complete the surgery without any issues.The surgery was completed successfully with no known impact to the patient.This report is for an unknown 95mm helical blade.This is report 2 of 3 for (b)(4).
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Manufacturer Narrative
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No concomitant devices ¿ the helical blade inserter was re-reviewed based upon new information.Device used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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Update: the investigation conducted on the returned devices was completed on january 28, 2016.It was during this investigation that the helical blade inserter, which was originally documented to be a concomitant device, was actually broken at an unknown time during the procedure.Therefore, the device is being added to the complaint.This report is 2 of 4 for (b)(4).
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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