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Model Number TORPEDO, 4.0MM X 13CM |
Device Problem
Break (1069)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/31/2020 |
Event Type
Injury
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Manufacturer Narrative
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The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.
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Event Description
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It was reported, that during a acl procedure, the ar-8400td, was not working, the rep removed the torpedo to clean it thinking it was clogged.The surgeon inserted the ar-8400td into the joint, the device was still not working.That case was completed using a different ar-8400td.After the case was completed the sales rep stated he took the ar-8400td apart and the inner metal blade was sheared off.The surgeon took x-rays at the end of the case, it was confirmed that nothing was left inside the patient.
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Manufacturer Narrative
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Complaint confirmed, the tip of the inner tube broke off.Damage was observed on the edges of the outer tube window.The cause is undetermined, however a likely cause of the event is prying/leveraging the device during use.
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Search Alerts/Recalls
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