WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - NAILS: FEMORAL; ROD, FIXATION, INTRAMEDULLARY
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Device Problem
Use of Device Problem (1670)
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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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This report is for an unknown nail.Part and lot numbers are unknown; udi number is unknown.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.(b)(4).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 (b)(6) 2020, the patient underwent a removal procedure of an unknown femoral nail because the surgeon thought that the reported nail was long and wanted replace with a shorter nail.The initial surgery was 12 weeks ago.During the revision procedure, the reported nail and 3 unknown screws were removed and was replaced with a shorter nail with 2 screws.It was mentioned that there was no complaint or breakage against the original implants that were explanted.The procedure was successfully completed without surgical delay.Patient status was good.Concomitant medical products: unknown locking screw (part # unknown, lot # unknown, quantity 3).This complaint involves one (1) device.This is 1 of 1 for report (b)(4).
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Search Alerts/Recalls
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