Model Number ACL TIGHTROPE WITH FIBERTAG |
Device Problem
Defective Device (2588)
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Patient Problem
Insufficient Information (4580)
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Event Date 08/14/2023 |
Event Type
malfunction
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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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Event Description
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On 8/24/2023, it was reported by a distributor via sems-06014472 that an ar-1588rtt acl fibertag tightrope straight needle was not attached to the sutures.This was discovered during a procedure on (b)(6) 2023.Additional information requested.
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Search Alerts/Recalls
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