MAUDE Adverse Event Report: ARTHROCARE CORP. DISPOSABLE FIRSTPASS SUTURE PASSER, SELF

Catalog Number 22-4038

Device Problem Crack (1135)

Patient Problem No Information (3190)

Event Date 10/13/2020

Event Type  malfunction  

Event Description

It was reported that during a rotator cuff surgery, the firstpass suture passer was being used to pass an ultrabraid and it was used as per normal and correctly but a loud crack was heard and the jaws of the product were no longer functional.The procedure was completed with a backup device and there was no patient harm nor injury.There was a slight delay for a few minutes.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H3, h6: the reported device, used in treatment, was returned for evaluation.There was a relationship found between the reported incident and the returned device.A review of the device history records for the reported lot number showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolate event.Clinical evaluation was completed and concluded that based on a review of the complaint details provided, nothing broke inside of the patient.Additionally, it was reported, the procedure completed with a backup device with a slight delay.Since there was no patient harm nor injury, no further clinical/medical assessment is warranted at this time.Visual evaluation shows the device jaws are locked open.No manufacturing discrepancies observed.Functional test was performed on the returned device using a foam to replicate the tissue.Lever actuation was activated.The jaws mechanism is damaged and the device could not hold the foam while passing a stitch.The complaint was confirmed.Factors that could have contributed to the reported event include: (1) excessive force.No containment or corrective actions are recommended at this time.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

Event Description

It was reported that during rotator cuff surgery, the firstpass suture passer was being used to pass an ultrabraid and a loud crack was heard and the jaws of the product was no longer functional.The device was used as per normal and correctly.Nothing broke inside the patient.The procedure was completed with a backup device and there was no patient harm nor injury.There was a slight delay for a few minutes.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

• Brand Name: DISPOSABLE FIRSTPASS SUTURE PASSER, SELF
• Type of Device: PASSER
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 10786301
• MDR Text Key: 214588455
• Report Number: 3006524618-2020-00948
• Device Sequence Number: 1
• Product Code: HWQ
• UDI-Device Identifier: 00885556724545
• UDI-Public: 885556724545
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 22-4038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2020
• Date Manufacturer Received: 12/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1