WRIGHTS LANE: SYNTHES USA PRODUCTS LLC 11MM TI LATERAL ENTRY FEMORAL RECON NAIL-EX/400MM/RT-STERILE; ROD, FIXATION, INTRAMEDULLARY
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Model Number 04.003.460S |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Non-union Bone Fracture (2369)
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Event Type
Injury
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Manufacturer Narrative
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It is unknown when the event occurred.This report is for 1 (one) lateral entry femoral recon nail/unknown lot.Complainant part is not expected to be returned for manufacturer review/investigation.Device is not distributed in the united states, but is similar to device marketed in the usa.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 a patient underwent a revision of a 11 mm lateral entry femoral recon nail and at least two (2) recon screws (5.0 mm locking screws) on (b)(6) 2017 due to nonunion.All devices were removed intact, and the patient was then revised to another recon nail.There were no complications during the revision of the implants and no additional interventions were required to complete the surgery successfully.The patient is reported to be in stable condition.This complaint involves at least three (3) devices.Concomitant devices reported: unknown screws (part # unknown, lot # unknown, quantity # unknown).This report is for the nail.This report is 1 of 2 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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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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