|
Model Number SS OPEN CNULA,BLNT,DETACHABLE HNDL |
Device Problem
Material Twisted/Bent (2981)
|
Patient Problem
Insufficient Information (4580)
|
Event Date 02/05/2021 |
Event Type
malfunction
|
Event Description
|
It was reported during a hip scope procedure the surgeon was using the ar-6507-03 and ar-6507-04 to get into joint, and both devices bent.See source data and images attached.
|
|
Manufacturer Narrative
|
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Complaint confirmed, the device was found to be severely bent.A likely cause of the event is user-applied mechanical forces.
|
|
Search Alerts/Recalls
|
|
|