WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12MM/130 DEG TI CANN TFNA 400MM/RIGHT-STERILE ROD, FIXATION, INTRAMEDULLARY
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Model Number 04.037.260S |
Device Problem
Break (1069)
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Patient Problem
Failure of Implant (1924)
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Event Type
Injury
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Manufacturer Narrative
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Reporter is synthes sales consultant.
A review of the device history records has been requested.
The device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.
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 a patient underwent a revision surgery on (b)(6) 2018 as it was found out that a trochanteric femoral nailing advanced (tfna) nail broke at the junction of the helical blade a few months after a patient had a hip fracture fixed with tfna.
The nail was removed, and a total hip arthroplasty was done.
There were no fragments generated from the broken device and it was removed without incident.
Surgical delay and procedure outcome is unknown.
Patient status is unknown.
Concomitant devices reported: tfna fenestrated helical blade 100mm (part# 04.
038.
400, lot# h557037, quantity 1); screw (part # unknown, lot # unknown, quantity 1).
This report is for one (1) tfna nail.
This is report 1 of 1 for complaint (b)(4).
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