Catalog Number 230261 |
Device Problems
Corroded (1131); Material Discolored (1170)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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To date the device involved in the reported incident has not been received for evaluation.An investigation has been initiated based on the reported information.
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Event Description
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This instrument has corrosive from the tip and rust inside the instrument during orthopedics surgery in direct contact with patient under normal conditions and there isn't any broken parts inside the patient.No harm done.
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Manufacturer Narrative
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On 5/12/2016 integra investigation completed.Method: failure analysis, device history evaluation.Results: failure analysis: failure analysis cannot be completed due to the lack of information received to perform a complete investigation.Product has not been returned for evaluation.Unconfirmed complaint.Device history evaluation: dhr review: nonconforming product report / nonconforming material report history: none.Variance authorization / deviation history: none.Engineering change order/manufacturing change order history: none.Corrective action preventive action history: none.Health hazard evaluation history: none.Conclusion: root cause cannot be determined due to the lack of information received to perform a complete investigation.Product has not been returned for evaluation.
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Search Alerts/Recalls
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