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Model Number TORPEDO, 4.0MM X 13CM |
Device Problem
Connection Problem (2900)
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Patient Problem
Discomfort (2330)
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Event Date 11/12/2021 |
Event Type
malfunction
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Manufacturer Narrative
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During returned device evaluation, a reportable malfunction was discovered.Complaint confirmed.One unpackaged ar-8400td was received for investigation.Visual inspection under magnification revealed that the inner diameter of the outer tube hood was chipped.The cause remains undetermined, although a probable cause can be attributed between interference between the device and bone or other instrumentation during use.
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Event Description
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On (b)(6) 2021, it was reported by an arthrex employee via sems that an ar-8400td torpedo was shaped different from its usual and there was a discomfort when it was attached to the handpiece.This was discovered during a procedure on (b)(6) 2021.A new device was used to complete case and patient was not affected.During returned device evaluation, a reportable malfunction was discovered.
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Search Alerts/Recalls
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