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

Catalog Number 22-4038

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/10/2019

Event Type  malfunction  

Event Description

It was reported that during rotator cuff repair, the first pass got broken inside the patient.Pieces were removed with grasper from the patient.The procedure was completed without delay using a back-up device.No patient injury 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 reported disposable firstpass suture passer device, intended for use in treatment, was returned for evaluation.A relationship between the devices and reported incident was established.From the information provided, ¿the first pass got broken inside the patient.Pieces were removed with grasper from patient.¿ customer¿s complaint was confirmed.The suture trap is damaged and missing a small portion on the left side.No manufacturing discrepancies were observed.During functional evaluation the two step trigger performed as intended, the jaw could be opened and closed, and the needle could be extended without any issues.The needle went through a foam model and passed a stitch as intended.The suture capture shows no visual or functional discrepancies.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) tip damaged between passes.The instruction for use was reviewed and found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.There were no indications during manufacturing record review 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: 9281751
• MDR Text Key: 165201357
• Report Number: 3006524618-2019-00538
• 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: 01/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2022
• Device Catalogue Number: 22-4038
• Device Lot Number: 2035894
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1