WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - END CAPS: RAFN; NAIL, 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 rafn end cap/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 the patient underwent a procedure on an unknown date, with retrograde approach for a supracondylar fracture including those with intraarticular extension, morbidity obese, and non-union at supracondylar femur.Postoperatively, there was a union of fracture noted and patient had a supracondylar femur fracture treated with debridement and open reduction internal fixation (orif) with lateral va supracondylar femur plate.Patient went on to non-union with recon using rafn and new va locking plate.There was an evidence of healing reported.No further information is available.This report is for an unknown rafn end cap.This is report 2 of 3 for (b)(4).
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Search Alerts/Recalls
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