Model Number ACL TIGHTROPE WITH FIBERTAG |
Device Problem
Material Twisted/Bent (2981)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/05/2024 |
Event Type
malfunction
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Event Description
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On 01/05/2024, it was reported by a distributor via (b)(4) that an ar-1588rtt acl fibertag® tightrope had a knot in the assembly.This was discovered during a right acl reconstruction on (b)(6) 2024 with no effect on the patient.
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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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