WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - NAIL HEAD ELEMENTS: RAFN SPIRAL BLADE; ROD, FIXATION, INTRAMEDULLARY
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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Joint Dislocation (2374)
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Event Type
Injury
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Manufacturer Narrative
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This report is for an unknown nail head elements: rafn spiral blade/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.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.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, the patient underwent an unknown procedure with retrograde approach for an ipsilateral hip/shaft, ipsilateral femur/tibia, poly trauma and morbidity obese at segmental femoral shaft with basicervical neck fracture.Postoperatively, there was a union of fracture noted and patient had an unstable multilig knee with proximal tibia fracture dislocation, lisfranc fractures and contralateral rotatrion ankle fracture.There was an evidence of healing reported.This report is for one (1) unk - nail head elements: rafn spiral blade.This is report 2 of 4 for (b)(4).
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Search Alerts/Recalls
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