|
Catalog Number AR-6060-90 |
Device Problem
Device Or Device Fragments Location Unknown (2590)
|
Patient Problem
No Code Available (3191)
|
Event Date 07/26/2016 |
Event Type
Injury
|
Manufacturer Narrative
|
Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.The device was requested for evaluation but was not returned, therefore the complainant's event could not be verified.The cause of the event could not be determined from the information available and without device evaluation.Device history record review revealed nothing relevant to this event.Based on the information provided, the most likely cause(s) of this event is the use of excessive force and/or prying/levering with the tip fully exposed on the device during use.This is the first complaint of this type for this part/lot combination.The potential cause(s) of this event will be communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.Device was discarded by the facility.
|
|
Event Description
|
It was reported that during a shoulder arthroscopy, a suture snare suture passer, ar-6060-90, was being used.The instrument was used to pass two sutures and upon inserting the passer to pass the third suture, it was discovered that a small fragment of the nitinol wire loop was missing.The device was discarded during the procedure.The surgeon took an x-ray of the shoulder.It was unconfirmed if the small fragment was left inside the patient or lost outside the patient's body.
|
|
Search Alerts/Recalls
|
|
|