Model Number 4.75MM BC KNOTLESS SWIVELOCK |
Device Problem
Defective Device (2588)
|
Patient Problem
Insufficient Information (4580)
|
Event Date 02/20/2024 |
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 2/21/2024, it was reported by a sales representative via email that an ar-2324kbcc biocomposite knotless swivelock mechanism locked up and would not tension.The surgeon ended up cutting the repair sutures and removing the anchor.The case was completed using another ar-2324kbcc biocomposite knotless swivelock.This was discovered during an rcr procedure on (b)(6) 2024.
|
|
Search Alerts/Recalls
|