Catalog Number 904053 |
Device Problem
Failure to Advance (2524)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 12/03/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).Udi#: (b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-05615.
|
|
Event Description
|
It was reported that during right shoulder arthroscopic anterior and posterior labral repair with capsulorrhaphy.The surgeon experienced two malfunctions with the ez-pass.Passer would not advance nitinol kite.No reported harm to the patient.
|
|
Event Description
|
Upon receipt of additional information, it has been determined that this event was previously reported under 0001825034-2019-05795.The initial report was forwarded in error and should be voided.
|
|
Manufacturer Narrative
|
Upon receipt of additional information, it has been determined that this event was previously reported under 0001825034-2019-05795.The initial report was forwarded in error and should be voided.
|
|
Search Alerts/Recalls
|