Model Number ACL TIGHTROPE WITH FIBERTAG |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
Insufficient Information (4580)
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Event Date 02/12/2024 |
Event Type
malfunction
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Event Description
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On 2/12/2024, it was reported by a distributor via (b)(4) that an ar-1588rtt acl fibertag tightrope needle came off during the first pass.This was discovered during an acl procedure on (b)(6) 2024.The case was completed using a new device.All fragments were removed.
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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.If the device becomes available for evaluation, a follow-up report will be submitted.
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Search Alerts/Recalls
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