Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Limb Fracture (4518)
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Event Date 12/20/2021 |
Event Type
Injury
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Manufacturer Narrative
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A product investigation was performed for this device.The actual device was not returned to the manufacturer for evaluation.The root cause of the non-union is undetermined.There is no way to predict a non-union or failure to heal.The radiographic and clinical data were reviewed by a sign orthopedic surgeon.This failure does not indicate a defect in the product.A minimal risk is associated with this failure.Sign fracture care international continues to monitor these events as part of our post market surveillance activities.
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Event Description
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We became aware on 12/28/2021 that a sign im nail implanted to repair a fracture was replaced due to a non-union.The im nail was replaced with a 10mm x 360mm standard im nail per the sign technique manual.
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Manufacturer Narrative
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A product investigation was performed for this device.The actual device was not returned to the manufacturer for evaluation.The root cause of the non-union is undetermined.There is no way to predict a non-union or failure to heal.The radiographic and clinical data were reviewed by a sign orthopedic surgeon.This failure does not indicate a defect in the product.A minimal risk is associated with this failure.Sign fracture care international continues to monitor these events as part of our post market surveillance activities.
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Event Description
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We became aware on 12/28/2021 that a sign im nail implanted to repair a fracture was replaced due to a non-union.The im nail was replaced with a 10mm x 360mm standard im nail per the sign technique manual.
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Search Alerts/Recalls
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