MAUDE Adverse Event Report: ARTHROCARE CORP. DISP FIRSTPASS STR PASSR SELF; PASSER

Model Number 22-4038

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 02/19/2020

Event Type  Injury  

Event Description

It was reported that, during a shoulder arthroscopy, when the firstpass suture passer was fired, the product locked inside of the joint.After finally getting product out of joint it was noticed that the jaw was stuck in closed position and the needle was bent out of the side of the jaw, instead of firing up through the self-capture mechanism.A replacement product was on hand.It is unknown if surgery was delayed as consequence of the allegation.There was a slight damage to the patient tissue.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10 h3,h6: the disposable firstpass suture passer device, used in treatment, was returned for evaluation.A relationship between the device and reported incident was established.A review of manufacturing records for the reported lot number 2042053 found no non-conformance's or anomalies during manufacturing process related to the reported event.A complaint history review found no related failures; this failure mode will be trended to assess for any necessary corrective actions.Clinical evaluation was completed and concluded that based on the product evaluation and the information provided, the root cause of the grasping issue was likely due to a procedural/user error.The impact to the patient was the report of slight damage to the patient¿s tissue.No further clinical/medical assessment is warranted at this time.Should any additional medical information be provided this complaint will be re-assessed.Visual inspection shows the device needle is bent and stuck out of the jaw on the side.The two step trigger is locked and the device can't be tested.The complaint was verified.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: (1) excessive force (2) tissue thickness (3) debris or damage in the device tip between passes.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.

• Brand Name: DISP FIRSTPASS STR PASSR SELF
• Type of Device: PASSER
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 9875474
• MDR Text Key: 187909727
• Report Number: 3006524618-2020-00122
• Device Sequence Number: 1
• Product Code: HWQ
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 06/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/08/2022
• Device Model Number: 22-4038
• Device Catalogue Number: 22-4038
• Device Lot Number: 2042053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2020
• Date Manufacturer Received: 04/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other