Model Number ACL TIGHTROPE WITH FIBERTAG |
Device Problem
Detachment of Device or Device Component (2907)
|
Patient Problem
Insufficient Information (4580)
|
Event Date 02/05/2024 |
Event Type
malfunction
|
Manufacturer Narrative
|
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.
|
|
Event Description
|
On 2/5/2024, it was reported by a distributor via (b)(4) that an ar-1588rtt acl fibertag tightrope detached from the needle.This was discovered during a quad link acl procedure on (b)(6) 2024.The quad link was completed by using a free mayo needle instead.All broken fragments were removed.
|
|
Search Alerts/Recalls
|