WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - NAILS: HINDFOOT ARTHRODESIS NAIL; NAIL, FIXATION, BONE
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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 01/01/2021 |
Event Type
Injury
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Manufacturer Narrative
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This report is for an unknown hindfoot arthrodesis nail/ 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 (b)(6) 2021 the patient underwent a fusion of her calcaneus, talus, and tibia using a hindfoot arthrodesis nail.During a follow-up appointment, it was discovered that the interlocking spiral blade backed out and needed to be removed.The other screws and nail are not planned were not removed during the revision on (b)(6) 2021.It is possible that the patient was walking on it (against surgeons post op orders) as there was slight radiolucency around the entry point of the nail as if it had been toggling.The sight looked infected.This report is for one (1) unknown hindfoot arthrodesis nail.This is report 2 of 3 for (b)(4).
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Search Alerts/Recalls
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