WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - NAIL HEAD ELEM: TFNA LAG SCREW; ROD, FIXATION, INTRAMEDULLARY
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Device Problem
Migration (4003)
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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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Product complaint # (b)(4).This report is for an unk - nail head elem: tfna lag screw/ unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/ investigation.Reporter is a j&j representative.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; 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 on an unknown date, patient underwent a surgical procedure.It's a trochanteric fixation nail advanced (tfna) nail inserted incorrectly, and it was removed.A successful removal was completed but they do want to report the lag screw in a face with a nail as not function or not locked.It is unknown if there was surgical delay.Patient outcome was unknown.Concomitant device reported: unk - nail head elements: tfna helical blade (part # unknown; lot # unknown; quantity: 1), unk - screws: nail distal locking (part # unknown; lot # unknown; quantity: 1).This complaint involves two(2) devices.This report is for (1) unk - nail head elem: tfna lag screw.This report is 1 of 1 for (b)(4).
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Search Alerts/Recalls
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