WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - END CAPS: TIBIAL NAIL; 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 Problems
Non-union Bone Fracture (2369); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
Injury
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Manufacturer Narrative
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510k: this report is for an unk - end caps: tibial nail/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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, the patient underwent removal of a synthes tibial nail and screws because of an infected nonunion.The original surgery was done in 2017 at an unknown location.The nail and one screw were removed successfully.Fragments of one broken proximal screw remained in the patient's body.This report is for one (1) unk - end caps: tibial nail.This is report 3 of 3 for (b)(4).
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Search Alerts/Recalls
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