WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - NAILS: RAFN; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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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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510k: this report is for an unknown expert retrograde/antegrade femoral nail (rafn)/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 antegrade intramedullary procedure for a closed displaced comminuted subtroch femur fracture with an associated injury of right acetabular fracture, splenic laceration, left pneumothorax.There was a known delayed union of fracture for about three (3) months duration and other complications of heterotopic ossification at imn entry site reported.Patient outcome is unknown.No further information is available.This report is for an unknown expert retrograde/antegrade femoral nail.This is report 1 of 1 for (b)(4).
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Search Alerts/Recalls
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