SYNTHES USA 11MM/130 DEG TI CANN TFNA 400MM/LEFT - STERILE; ROD, FIXATION, INTRAMEDULLARY
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Catalog Number 04.037.161S |
Device Problem
Break (1069)
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Patient Problem
No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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Device used for treatment, not diagnosis.Patient weight not provided for reporting.(b)(4).Device is not expected to be returned for manufacturer review/investigation.(b)(4).Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received.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 hardware removal and revision was performed on (b)(6) 2016 due to a broken tfna.The original procedure to repair a left femur fracture was performed on (b)(6) 2015.Subsequently, it was discovered that the tfna had broken at the point of interface with the helical blade.The removed hardware included the broken tfna, one intact helical blade and one intact locking screw.The patient was revised to an oncologic total hip prosthesis.The procedure was completed successfully with the patient in stable condition.This complaint involves one device concomitant devices reported: helical blade (part #04.038.305s, lot #unknown, quantity 1), locking screw (part #04.005.540, lot #unknown, quantity 1).This report is 1 of 1 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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