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

Model Number 22-4038

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/04/2020

Event Type  malfunction  

Event Description

It was reported that, during a shoulder surgery, the metal piece of the firstpass suture passer broke off into fragments inside the patient.The metallic pieces were removed from the patient by means of arthroscopic graspers.The procedure was successfully completed without delay using a back-up device.No patient injuries or other complications were reported.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, used in treatment, was returned for evaluation.A relationship between the device and reported incident was established.From the information provided, ¿the metal piece of the firstpass suture passer broke off into fragments inside the patient." visual inspection shows the device is missing the suture capture, part of it has been returned.No other manufacturing discrepancy observed.Functional test was performed on the returned device using suture and foam to replicate the tissue.The needle was able to penetrate thru the foam and pass a stitch.Lever actuation was smooth.Functional test was achieved successfully.The complaint was verified.The root cause could not be determined with confidence; however, factors unrelated to the manufacturing or design of the device that could have contributed to the reported event include: (1) excessive force.(2) tissue thickness.(3) damage of the 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: 9779749
• MDR Text Key: 181754421
• Report Number: 3006524618-2020-00086
• 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: 04/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2022
• Device Model Number: 22-4038
• Device Catalogue Number: 22-4038
• Device Lot Number: 2040169
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2020
• Initial Date Manufacturer Received: 02/05/2020
• Initial Date FDA Received: 03/03/2020
• Supplement Dates Manufacturer Received: 04/08/2020
• Supplement Dates FDA Received: 04/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1